SsdwLab 5  Prenatal Screening Software

  Presentation

At the beginning of 1995 the first version of the SSD software for Down’s syndrome screening was released. It was very well received and continues to be used by gynecologists and prenatal diagnosis units. At the end of 1996 the second version was introduced, for use by clinical analysis laboratories. Both versions were developed in the DOS environment, specifically with the OPEN ACCESS IV integrated package.

Later on, Ssdw 1 and 2 and SsdwLab 3 and 4 versions were released for use with Windows operating systems, 3.11 for the first and 95/98/NT4/2000 for the others.

The current version, SsdwLab 5, has been completely redesigned and developed with the most up-to-date visual programming tools (Visual Basic 6, Access 2000, DocToHelp 6, etc.) for its implementation in Windows 2000, XP and Vista operating systems.

As in previous versions, the method described by GE Palomaki and JE Haddow in 1987 is used to calculate the likelihood ratio (Palomaki GE, Haddow JE. Maternal serum alpha-fetoprotein, age, and Down syndrome risk. Am J Obstet Gynecol 1987; 156:460-3), by means of the mathematical calculations for Gaussian multivariate distribution published by TM Reynolds and MD Penney in 1990 (Reynolds TM, Penney MD. The mathematical basis of multivariate risk screening: with special reference to screening for Down's syndrome associated pregnancy. Ann Clin Biochem 1990; 27:452-8).

This new version facilitates the simultaneous use of up to 10 biochemical and/or ultrasound markers with known Gaussian distribution and correlation coefficients, as well as up to 15 markers with known trisomy 21 positive and negative likelihood ratio, and another 15 markers for trisomy 18. The software estimates the trisomy 21 and 18 (18-13) individual risks for each single marker (combined with the maternal age) and for the different combinations of markers of any type, defined in the Screening Profiles which can be completely customized by the user.

A wider range of equations has been added to the traditional and valued characteristics of previous versions (configuration and personalization facilities, automatic calculation of medians and correction factors, multi-language printing, data server connection, e-mail reports, control of perinatal results and screening quality, etc.). Specifically, equations for medians and maternal weight correction, new correction factors which can be fully defined and calculated by the user, greater precision in risk estimation for single pregnancies and mono and dichorial twins, as well as highly effective procedures for controlling screening quality, such as the percentage of positive cases, the median MoM of the different markers and screening test effectiveness.

The program fulfills the criteria specified by the NHS for Down’s syndrome screening software. National Down's Syndrome Screening Program for England. National Specification for Risk Calculation Software and Guidance on Implementation, October 2004. http://www.nelh.nhs/screening /

The total user-configurability of this software, as is usual in our computer applications, allows innovations in the area of prenatal aneuploidy screening to be applied by means of our programs and their updates, to biochemical or biochemical-ultrasound screening tests.

The authors are confident that this new version, which incorporates the latest innovations published in the broad area of prenatal detection of congenital anomalies, will contribute to the improvement of the clinical performance of prenatal aneuploidy screening.

  SsdwLab version 5 specifications

• Developed using visual programming tools: Visual Basic 6, Access 2000, DocToHelp 6, VsView 7, etc.

• Usable under Windows 2000 / XP operating systems, in a single workstation or a network.

• The reliability and precision of the algorithms and the internal mathematical calculations of SsdwLab5 have been proved with the prenatal screening software: “Prenatal Screening Decision Support QA Tools” version 2.0 from “Media Innovation Ltd”, partnership of University of Leeds and UK National Screening Committee (http://www.media-innovations.ltd.uk/dsqainfo) wich constitutes a prenatal screening reference software for validation of  trisomy 21 software programs in the United Kingdom.

• Database Microsoft Jet 4.0 engine from Microsoft Access 2000 that guarantees the compatibility with other systems and the analysis and treatment of the data (not protected) by means of other commercial software for database administration. See the section of limitations in the same chapter.

• Automatic adaptation, according to Windows Regional Configuration, of the numeric format (comma or point) and different international date formats.

• On screen display in multiple languages.

• The combo boxes that contain field names are visualized, when they are from Patient's table, translated to the predetermined screen language by means of a tool tip text that appears when locating the mouse pointer under each field name. For grids, the translation of the fields name is direct on each column heading text.

• Hardware protection against copy, not authorized access, etc. using an USB Hasp HL key and software protection (three levels of security by user's code and password) of record's access, modifications, configuration, reports, etc.

• Each license of the Program, necessary for each workstation in which SsdwLab5 executes, is bound to a HASP HL key that possesses an unique identifier number. The HASP HL key allows Program license Internet upgrade in cases of new versions, updates, etc.

• Historical file containing new patient records,  modifications to patients records, identification of the user that has carried out them as well as the date and time. To accomplish the legislation on security measures of automated files that contain data of personal character (Royal Ordinances 994/1999 of June 11 and 195/2000 of February 11) and the patient's rights (as the Law 21/2000 of December 29 from the Generalitat of Catalunya concerning the rights to the health and the patient's autonomy and the clinical documentation). This is a protected file that can be visualized and print but not modified by any user, independently of their access level, neither by means of any database administration software.

• Control and automatic recording of Program accesses and exits from different users in single workstations and networks.

• Recording of accreditation of sonographers that assess ultrasound Gaussian markers (those biometry related) and configurable lock of  who are not accreditated.

• Definition of an unlimited number of Screening Profiles with simultaneous use up to 10 biochemical and/or ultrasound markers with known Gaussian distribution and correlation coefficients, as well as up to 15 markers with known trisomy 21 positive and negative likelihood ratio, and other 15 markers for trisomy 18.

• Lock of the configuration for the most important parameters in the Screening Profiles when these have already been used to calculate the Risk of, at least, a patient (number and type of the markers and number and type of the correcting factors). It can be defined a new Screening Profile taking as base anyone of the existent ones, although their configuration is locked. 

• Biochemical and ultrasound markers, correcting factors, measure units, cut-off levels, truncation limits, population parameters, etc. totally configurable and user definable.

• Calculation of gestational age from anyone of the following parameters: date of last menstrual period, ultrasound or biometry (CRL, BPD, FL, etc.) estimation of the weeks and days at a certain date, and concepción date.

• Definable and customizable configuration for each computer in a network environment (a Screening and Printing Profile can be configured on each computer).

• Selection of the moment in what Down's syndrome risk is estimated (at term or at the time of the test); and in the last case, correction possibility for the intra-uterine lethality by means of discreet method (in a concrete week) or continuous (variable according to gestational age, expressed in days, from a user revisable polynomial formula).

• Possibility to select the method of “prior” maternal age risk estimation.

• Estimation of combined risks "age-marker" for 21 and 18 (18-13) trisomies, for each individual marker and for the combination of all of those used in each Screening Profile in the first and in the second trimester of the gestation. Very complete information, in the same screen of the result of the risk calculation, presented from floating tool tip text to avoid an excess of active visual information, about the median values of each marker, likelihood ratios (LR) specific for trisomy 21 and 18 for each marker, as well as the combined LR for all the markers used for both trisomies, moment in which is considered the risk (at the time of the test or at term), combined risk only for Gaussian markers (when positive and negative LR markers are used simultaneously), maternal age in the probable date of  delivery, total days (and weeks and days) of gestational age for each used marker (very useful in sequential screening), gestational age that corresponds to a biometry used with an ultrasound marker, method of evaluation for the markers with positive and negative LR, etc.

• Neural tube defects (NTD) risk estimation by means of a MoM cut-off  with the second-trimester matern serum alpha-fetoprotein.

• Possibility to use only some markers of those included in a Screening Profile and of storing, without the intervention in the calculations of Risk neither appear in the printed Report, some or all the values for investigation, median calculation, modeling, etc. (very useful in first-trimester twin screening if we want to calculate Risk only by means of NT, but we want to have the values of the biochemistry for later evaluation).

• Possibility of the use of constant or variable populational parameters according to gestational age (mean log 10 MoM for T21 and 18).

• Optional calculation of the aneuploidy risk in twins with own populational parameters, and chorionicity differentiation.

• Automatic median calculation from data obtained of the own screening laboratory, as well as of the polynomial function (up to quartic, pondered by the number of determinations in every week of gestation or interval of a biometry) among the gestational age (in days), or a biometry in millimetres, and the value of each marker. Possibility of application of a reciprocal, exponential, 10 ^, log e or log 10 transformation to the polynomial function or the variable x. Possibility of direct introduction of the medians to carry out the same calculations in the biochemical markers.

• Possibility of manual introduction of the multiples of the median (MoM) in the estimations of Risk for verification of the correction of the calculations and quality control (UK NEQAS, etc.).

• Correction by a previous affected pregnancy of trisomy 21, 18 or NTD.

• Selection of the correction method for the patient's weight (exponential (10 ^) or reciprocal) and automatic calculation of the correcting factors coefficients and the median of the patients' weight (from the own database) in both methods.

• Automatic calculation of the Median of the multiples of the median (MoM) for each Marker as a quality screening test.

• Automatic calculation (from the own database) of the correcting factors (covariables) for the 15 user definable.

• Automatic calculation (from the own database) of the Gaussian distribution population parameters for each one of the markers (median and standard deviation), when an enough number of tests have used the marker.

• Automatic calculation (from the own database) of the correlation coefficients among markers, when an enough number of tests have used the marker.

• Automatic calculation of the Percentage of Positive Cases, median of the MoM of each marker and of the effectiveness of the screening test (sensibility, specificity, etc.); in this last case if the perinatal result is reported.

• Recovery (without necessity of typing them again ) of the administrative and pregnancy data (in the case of being the same one) in patients with a previous test.

• Possibility to access  a Server that contains the patients filiation data and automatic introduction in the database and screens of the Ssdwlab5 program. This access is open to the most popular databases via ODBC.

• Import of patient record groups, whose tests have been carried out by means of other software programs, for automatic report edition, analysis of screening effectivenes, amplification of the possibilities of risk estimation, etc. This access is open to the most popular databases via ODBC.

• The compatibility of SsdwLab5 ODBC connection has been proved with the following databases: Microsoft SQL Server 2005, Intersystems CACHE 5.0 and ORACLE Database 10g.

• Completely customizable report, with possibility of a header logo inclusion, and printable in any language of the western alphabet.

• Printing of multiple reports, selected by date or registration number, with election of the number of copies, print of a postnatal control sheet, electronic signature, etc. Differentiation among the language in which one writes the original and the copies for each one of the different reports.

• Possibility to create automatic compressed and encrypted files, from reports selected for electronic mail distribution, intranet etc.

• Availability of an independent computer software, of limitless distribution, that allows decryption, visualization and print of report files sent using the technique mentioned in the previous paragraph.

• Automatic system of selected record export and creation of new Microsoft Access databases and tables with this records, for shipment to centralized systems via e-mail, diskette, etc. (multicentre studies, quality control, etc.)

• Integrated backup system (Backup Zip) with warning of the convenience of carrying it when it has not been carried out in the 3 previous days.

• Data entry indistinctly by the mouse or the keyboard.

• Visual calendar for the introduction of dates, without typing the digits, with the purpose of avoiding the frequent errors in this type of fields.

• Automatic correction of certain type errors in data input.

• Optional recording of requesting doctors and hospitals, indications and results of invasive techniques, ultrasound findings, perinatal result for quality control, etc. totally configurable and user definable

• Centralization of all patient data and episode (for a certain test) in an unique form and in the same record of the data Table.

• Possibility to install Databases in an independent remote computer which includes the Program executable in single a workstation as in a network, and with independent configuration of the predetermined Screening Profile, as well as the printing for each client computer.

• Patient's and episode quick search by surname, clinical record number, NIC or PIC, indistinctly, or by any field by means of a visual SQL interrogation with two levels of accessibility (basic and advanced).

• Automatic estimation of the typical parameters for screening effectiveness (sensibility, specificity, etc.) from the patients already tested database, as well as possibility of hypothesis formulation with different risk cut-off levels.

• User definable limitation of the number of records that are presented simultaneously in the screen to increase patient search speed.

• Very complete Help, contextual in the status bar and when allocating the mouse pointer under the data fields, as well as Windows type with Content, Index and word Search.

• Hardware and software diagnostic program installed on the computer.

  CD ROM contents

This version of the Program is presented in CD ROM support and includes 4 programs, each one installed in a different directory: SSDWLAB5 that constitutes the program of aneuploidy risk estimation for a single workstation or for a network server; SSDWLAB5_CLIENTE, to install the computer clients on a network; PRTSSDW5, program of report printing for remote computers and HASPINSTALL, to install the software protection key USB HASP HL Pro.

  Hardware minimum requirements

PC compatible computer with Pentium processor or equivalent at 1 GHz, with a minimum of 256 Mb of RAM memory. It should have a CD ROM reader, 200 Mb of free space in the hard disk, 1 USB free port and a screen resolution of 800 x 600 pixels.

It is very advisable to dispose of a UPSS (Uninterrupted Power Supply System) to avoid the corruption of the databases in the event of failure in the electric supply.

  Software minimum requirements

Operating system: Windows 2000 / XP. Regional configuration of a western country with international alphabet. It is very advisable to use a date's configuration with four digits in the year. It is advisable to have installed Internet Explorer (with Outlook Express) version 5 or later, to make backup copies and to send reports via e-mail; and Microsoft Access 2000 for database queries and to facilitate the ODBC configuration.

The use of a continuous up-to-date Antivirus program, and the realization of periodic backup copies, is of great importance to avoid the possible lost of data secondary to the inadvertent access of these intruders.

  License

END-USER LICENSE AGREEMENT FOR SsdwLab5 PROGRAM. IMPORTANT. READ CAREFULLY:

This End-User License Agreement ("EULA") constitutes a legal agreement between you (either an individual or a single entity) and the authors and companies who own the Program, in respect of above-identified software which includes software components and associated media, printed materials and "on screen" or electronic documentation ("SOFTWARE").

By installing, copying, or otherwise using the SOFTWARE PRODUCT, you agree to be bound by the terms of this EULA. If you do not agree to the terms of this EULA, you are not authorized to use the SOFTWARE PRODUCT.

The SOFTWARE PRODUCT is protected by copyright laws and international copyright treaties, as well as other intellectual property laws and treaties. The SOFTWARE PRODUCT is licensed, not sold.

USE: The possession of a License (which means you have a SsdwLab5 program CD ROM and a HASP HL key, programmed for its execution, with the same and unique identification number in both, all distributed by SBP-SOFTWARE CB or their legally authorized representatives) grants you the following rights and limitations:

Use of all the functions of the program on a single computer, or on a computer network, under the conditions that are detailed in this "EULA".

Technical support via e-mail during the first five years after its acquisition, free during the first year from the moment you receive the program's CD ROM and the HASP HL key, of the latest or only acquired License.

You may not sell, rent or lease the SOFTWARE PRODUCT. Reverse Engineering, Decompilation, and Disassembly of the SOFTWARE it is not allowed.

The End-User will be responsible for the custody of the CD ROM and the Hasp HL keys which grant the possession of the respective Licenses and SBP Software CB will only replace them in the event that these are faulty.

The possession of a License for the use of the SsdwLab5 program allows its use, unlimited in time, for a single computer that will have a HASP specific HL key for its execution. The number of Licenses which each End-User has corresponds exactly with the number of HASP HL keys that have been acquired. The use of the Program on a Network needs as many Licenses (and HASP keys) as the number of workstations on which you want to use it, excepting the Server if this is not used as a workstation. The program proprietors or their legally authorized representatives will grant the Licenses. The holders of one, or more, Licenses will be able to download without additional cost, but with previous identification of the license number/s, the successive Program upgrades on the web: www.sbpsoftware.com , while no modification will be done to the second number corresponding to the version (secondary version number indexed in "Properties of the SsdwLab5 Project " of the Visual Basic 6 compiler and in the “About SsdwLab5” form of the software) acquired, and you will have a 50% discount for the acquisition of the remaining upgrades or new versions.

The End-User will be responsible for the knowledge and fulfillment of the laws, effective in his Country, relating to security measures for automated files that contain data of a personal nature, and of rights concerning the patient's health, autonomy and clinical documentation.

  Intelectual property and distribution rights

They are reserved, to the authors of the Program, all the intellectual property rights. SBP Software CB has the distribution rights of the SsdwLab5 program. The distribution of copies of the Program and its documentation, for any technical system whenever it doesn't has as objective the realization of security copies or the information of the personnel's attributed to a screening service that has License for their use (granted by the Program proprietors or their legally authorized representatives) is completely forbidden.

The royalties of the Program's background image belongs to Roger Lleixá and that of the general artistic design to Daniel's Lleixà.

  Distribution, information and maintenance

SBP SOFT 2007 S.L.
C. Joan Maragall 31, 1º C, 17002, Girona, Spain
Telephone & Fax: +34 972 212099
URL: www.sbpsoftware.com ; www.sbpsoftware.es
e-mail: info@sbpsoftware.com