User Guide - PregSafe

1 How This Manual Is OrganizedMany people read their user’s manual only as a last resort. If you are one of those, thefollowing paragraphs tell you where to find information when you need it.Chapter ITeaches you how to navigate in the PregSafe system.Chapter IIDetails the interactions with each screen display of the program. This section serves asa reference source that goes beyond the information and instructions contained in thescreen prompts, the help screens, and general human intuition.2 Welcome to PregSafePregSafe is a state-of-the-art computer program that interprets both maternal serum andamniotic fluid alpha-fetoprotein results, with the optional use of other serum andultrasound markers in the first and second trimester of pregnancy. PregSafe calculatesa patient’s individual risk of carrying a pregnancy affected with either an open neuraltube defect or Down Syndrome, and issues an interpretive report. If assay results arepresent for AFP, hCG and uE3, PregSafe will also indicate whether the patient is atincreased risk for Trisomy 18 or Smith Lemli Opitz syndrome (SLOS), if the user hasconfigured it to do so. Other markers, such as Dimeric Inhibin A or Nasal Bone may beadded to improve the detection and false positive rates.PregSafe interpretation logic is based on an artificial intelligence, developed using anexpert system software language which is ideally suited for interpreting medicaldiagnostic tests. Artificial intelligence is a branch of computer programming that wasfirst developed over thirty years ago. An expert system is one type of artificialintelligence that codes the judgments and decisions of experts into rules or decisiontrees, identical to the thought processes of the experts. In effect, the consensus of theexperts is cloned in the software for widespread use.The expert knowledge used in PregSafe was derived from Clinical Biochemists,Geneticists, Pathologists, Obstetricians, Statisticians, and from published scientificliterature on the subject of interpreting serum marker results specific to prenatalscreening for Down Syndrome, OSB, Trisomy 18 and SLOS. Expert systems can bemodified easily to reflect changing medical opinions. PregSafe is no exception. As newknowledge becomes available and gains acceptance, it will be incorporated intoPregSafe, and new versions will be issued to licensed users.The process of getting started is simple. Read the following section on “InstallingPregSafe” to determine if you meet the system requirements, to determine the desiredApplication and Database setup, to install the Application, and to finally initialize thesoftware. If you have any problems or questions with the installation, do not hesitate tocontact Lilac Medicare.4