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iMed 6.1 User Manual

1. ccccccccscccsecseeccsenecccusnsecsuscesccueseuccusnsuscusnseesussenesanses 18 2 1 0 AGO Falen Dad di ii cde Sad de tada 18 2 a NS O A A Mae OETA A A IA ne TEC Se 18 21 9 SF ELE e Jesi S heats nts ae te O iat leh oat SiR thas tan eas 21 2 1 0 Medical Velle e ee le eee 23 4I Teame CERT TU 23 21 90 Uma EA ii E E leaena I ad 24 4 2 SEARCHING THE IMED DATABASE cccccececceccecccecccccccceccacececceacsuegueceeneauecesueaees 25 4 3 PRINTING PATIENT INFORMATION 2ccecceceecceccececcccceccccccccecceaceccenceceeaceneesesuseaes 26 ACA STATUS TOS tara anal se n ei er E notes etico ee ce eL Ee ELE 21 4 4 1 Selecting a Sub sets of Patients ccccccccccccsescceeccuccsescseessusssussauscauscauscauessussanes 27 4 4 2 Zooming into a Sub sets of Patients sees eene nnne nnns 28 4 5 CARE PROFESSIONALS ecten ete toco ev bbs ned id 29 iMed 6 User Manual 3 NOME Ec p iA RR toba detente cobol oe 30 WE vir eT Ut TT 31 4 7 1 Enabling data transfer capacity cccccccccccseccseecseecsueeseessuesseetseessueeseeesuesseessnesaees 31 4 7 2 Sending Data to MSBase iii ie 32 5 ADVANCED FEATURES canadian 33 Dor MED UPDATE A Eo ro EE MUERTA EM LUN SS MO Le DLP S LADE DESDE 33 9 2 MANAGING USER ACCOUNTS ti iod ta Deed pa aliu Rubr Ua ed T Dee DEUS 34 5 3 MANAGING IMED DATABASES ccocccocococoncncocnnononononnnconnnnnnnnnonnnnnnnnnnonanennnnerinanenanes 34 5 3 1 Flexifi
2. 6 10 11 1 1 17 18 3 5 20 B 22 B 24 27 M 29 30 31 March 2009 73 0 10 12 17 13 s Patient Profile Identification Medical History Diagnosis Notes Flexifields O Weekly Average Adherence 71 5 Monthly E Mar 2007 Apr 2007 May 2007 2007 2007 2008 2008 2008 2008 2008 2008 2008 2008 2009 z Feb 2007 P Oct Nov Dec Jan gl jan 2007 ormal injections Partial injections ultiple injections Patient Profile Identification Medical History Diagnosis Notes Flexifields lt lt Previous Next gt gt Average Adherence 79 5 0 Oct 2008 Nov 2008 Dec 2008 Jan 2009 Feb 2009 Mar 2009 N Multiple injections N Titration N Normal injections N Partial injections iMed also allows you to view treatment adherence and clinical parameters such as relapses or EDSS side by side This can be a helpful tool in working with patients to reinforce the importance of adhering to treatment CURIE Marie Age t 111 111 1111 x Treatments lg ns specific M symptomatic Mi Non pharma Events M Relapses I Medical conditions B Pregnancies Paraclinical tests 4 R1 d CSF gt Evoked Potentials Laboratory tests B Adherence B EDSS Time Scale Maximum B iMed 6 User Manual Gender F Deceased Date of MS onset Confirmed diagnosis Other medical conditions 15 03 1998 19 04 2000 Rhinitis Malignancy McDonald classification
3. screen provides the patient status regarding MSBase The in the column Enrolled To send data into your MSBase account directly from iMed your PC should have an Internet access Review your list of patients not yet enrolled and enrol additional patients if appropriate Then press the button Send Now iMed generates an anonymised dataset compatible with MSBase At the next prompt enter your MSBase Username and Password and press the Submit button The dataset is sent directly to your MSBase account The process may take a few minutes depending on the number of records to upload and the speed of your Internet connection Note If your PC has no Internet access or if for some reason the data transfer fails you still have the option to transfer your dataset from MSBase From your Internet browser go to www msbase org and log in using your MSBase Username and Password Then go to My data gt Upload data Click the Browse button and locate the MSBase dataset previously generated by iMed This dataset is called MSBaseExtract xml gz and is located under the iMed folder in a sub folder MSBase Dataset the path is probably c iMed MSBase_Dataset MSBaseExtract xml gz Press Submit to upload the dataset into your MSBase account A confirmation is displayed when the data transfer is completed iMed 6 User Manual 32 5 Advanced Features 5 1 Med Update New versions of Med can be downloaded and installed au
4. Limpor Last Name Fist Name Bith Date Gender BE050568 BE050568 05 05 1968 M v BEI0770 SS BEIS0770 sorso F 4 Data Mapping v eez eaa O gara E v pezsoss BeOS 2601 1966 M v pex foma 8 05 1853 M v BECKETT camine gt gt toser F v BECKHAM Cauda 29 0Vi962 F v BEDFORD Wilim 15 09 1949 M 4 pns A Rm AO A Med 6 User Manual 41 5 6 Med Reporting Module The Med Reporting Module iMedReporting exe is located in the Med installation directory by default C Program Files iMed and accessible from the Med program group This program lets you create your own templates of letters and reports with your clinic details and logo e g referral letters and generates customised printouts integrating patient specific data including your flexifields The Med Reporting Module works like a simple word processor such as WordPad You can start typing your report directly or you can copy and paste text from another word processor The top toolbar lets you adjust font and paragraph styles and colours The Insert menu lets you add images from your computer most formats are supported and special characters and symbols te Reporting Module File Edit Insert 2 El e El ES 4 Ho Aral fo gt 6 7 s K3 Last Visit Nb Days Missed Work Nb Days Rehabilitation Nb Days Hospital Nb Ambulatory Visits lAmbulation Index EIS IT8
5. wm Statistics to New e Delete Tr New Q Delete s Basic RS ESOO EA Care Professionals Date 27 05 2012 Examined by Status Impairment Calendar First visit McDonald classification EDSS Administrative NE Possible MS Ambulation index _ Routine Suspedsd relapse Poser classification Time to walk 8 m sec Phone Clinically Definite A1 Nine hole peg test sec Retrospective Disease course Relapsing Remitting Dominant hand v PASAT test 2H Since last visit Vital Signs Nb days missed work Height Nb days in rehabilitation Weight Nb days in hospital Blood pressure Nb of ambulatory visits Pulse Date next visit You must specify the visit date when the neurological status of the patient was assessed It is possible to create visits retrospectively simply by typing a date in the past If you are not sure of the exact date of the assessment but you do know the month and the year you should enter the 15th of the month If only the year of the visit is known you should record the assessment as occurring around the middle of that year The Visit page displays several tabs Basic EDSS Safety and Notes Basic Jase cT e Basic describes the purpose of the visit the patient s history since the last visit and evaluations of impairment levels The current MS classification and disease course are displayed here for reference but can only be modified in the Diagnosis form under the Patient
6. Disease cours Possible MS e RR since 12 years r 100 r 80 B 40 r 20 T T 1999 2000 2001 T T T 2002 2003 2004 2005 2006 2007 2008 2008 2010 2011 T T T 0 2012 45
7. Electronic Multiple Sclerosis Patient Clinical Database User Manual Version 6 Date of issue October 2012 MERCK Merck Serono Med 6 User Manual Copyright While every attempt has been made to ensure that the information in this document is accurate and complete some typographical errors or technical inaccuracies may exist Merck Serono SA does not accept responsibility for any kind of loss resulting from the use of information contained in this document This page shows the publication date The information contained in this document is subject to change without notice Any improvements or changes to either the product or the document will be documented in subsequent editions This software documentation contains proprietary information of Merck Serono SA All rights are reserved Reverse engineering of this software is prohibited No part of this software documentation may be copied photocopied reproduced stored in a retrieval system transmitted in any form or by any means or translated into another language without the prior written consent of Merck Serono SA Copyright 1999 2012 Merck Serono SA Geneva 9 chemin des Mines 1202 Geneva Switzerland a branch of Merck Serono SA Switzerland an affiliate of Merck KGaA Darmstadt Germany Merck Serono SA the Merck Serono logo iMed and Rebif are trademarks or registered trademarks of Merck Serono SA in Switzerland and or in other countries All other names are
8. You will be asked to choose a location where the iMed program must be installed then to iMed 6 User Manual 8 find where the existing Med database is located on your network See section 5 3 to learn more on sharing an Med database among several users 3 To update a previous version of iMed select Update a previous version and click Next You must then specify the folder where the previous Med program was installed by default C iMed Your current patient database will be automatically converted to the Med 6 0 format a process that may take a few minutes if you have many patients In the next dialogue box press Done to initiate the installation process When the installation is completed press Done to exit the setup program You are now ready to start Med 2 3 Starting iMed for the First Time Start Med by pressing the Start button on your desktop then choosing Med from the Programs menu or simply double click the iMed shortcut icon located on your desktop If you were using a previous version of iMed all your iMed data were automatically transferred into the current iMed during the program update process In addition your iMed Username and Password remain unchanged iMed will start immediately and you will be prompted to login If you are using iMed for the first time and you are not upgrading from a previous version of iMed a User identification form will appear asking for information about yourself In pa
9. CURIE 000518 DOE 000515 DUCHOSE 000349 SMITH 000523 TRUC 000350 TURNER 000352 AFAHUP 000353 AFEMEFADOM 000354 AFIMADYR 000355 AFOCURYMUT 000356 AHAHIPID 000357 AHEQAT 000358 AHYF 000359 AJAVU MIVILOK 000360 AJIREFUHOF 000361 AJOD 000362 AJOM 000363 AJUTEKAK 000364 AJYFYW 000365 AKIHULUQUTUQ 000366 ALUKYMYT 000367 ALUTYHUWOP 000368 AMOTAR 000369 AMUYUT 000370 AMYTYLEVIL 000371 APYLEJ 000372 AREHOVIMYD Rubus 000373 ATUFYMUDYQ 000374 ATUMAQYVEM 000375 AVACAKYWEW 000376 AVIQOV aa Total Patients The right hand side of the record can be Eligible Enrolled Complete The symbol indicates that you have not yet decided to enrol the patient on MSBase Use the button to enrol the appropriate patients on MSBase 4 7 2 Sending Data to MSBase e Birth Date NHS Number 11 06 1978 111 111 1111 01 12 1975 222 222 2222 12 12 1999 323 333 3333 08 02 1954 11 12 1987 20 03 1958 19 11 1971 07 12 1972 22 10 1956 07 11 1950 16 01 1962 15 07 1952 09 02 1960 12 09 1974 10 07 1959 02 09 1950 08 05 1965 08 05 1942 11 09 1967 14 08 1949 12 11 1958 07 06 1958 01 02 1965 05 04 1950 23 03 1985 31 07 1963 15 03 1968 02 08 1962 21 10 1958 13 01 1956 08 04 1950 MSBase ID Eligible Enrolled Co ete 4 zx o 5 EIEECEEETTTT T T E IT amp e m 9 m m e 9 W a elm nw u aW uuwui Oma EDITA EEE ADA EDADES Send your data directly to your persona MSB Send Now
10. Profile section e EDSS calculates the EDSS score based on the Functional System Score and the patient ambulation capacity of the patient You are also prompted to enter an EDSS manually this can be the same as the calculated one or different according to your clinical opinion of the patient Your EDSS score only is recorded in the iMed database The Functional System and Ambulation scores can be documented according to the Neurostatus format or the original Kurtzke format The EDSS requires a Functional System Score be entered by the user for each factor which is part of the scale The iMed software then uses a calculation method based on its own free interpretation of the above article to suggest an EDSS score There is no single accepted interpretation and this software provides only one of many possible interpretations In addition the overall EDSS level shown will vary according to the Functional System Score assigned to each factor by the individual User The EDSS level suggested by iMed for one patient may vary therefore and is intended for general informational purposes only User has full and final responsibility for the analysis review and assessment of data shown including the EDSS score Med 6 User Manual 19 The Kurtzke Expanded Disability Status Scale EDSS refers to a methodology described in John F Kurtzke Rating neurologic impairment in multiple sclerosis An expanded disability status scale EDSS Neurology 1983 1
11. Reporting Module see section 5 6 e If you are based in Switzerland Med also offers to print the German or French SVK report e f you are based in Denmark you can print the Kontrolskema report e f you are based in Italy you can print detailed Scheda Clinica reports specially tailored to your national requirements You can choose to print immediately or preview the report before printing In the Preview window you can zoom in on the pages that are being previewed print the pages or exit from the preview and therefore cancel the print command The Page Setup menu lets you change the default printer and page settings The default paper size can also be defined in the iMed Preferences under the Center Information heading iMed 6 User Manual 26 4 4 Statistics The Statistics View allows you to display summary statistics for all your patients or for a sub set of patients The upper frame of the Statistics View displays your list of patient records Click on a column header to sort the records by that column s data Click the same header again to invert the sort order The lower frame can display the distribution of several parameters the MS course the EDSS score at last visit the relapse rate the age at onset of MS the duration of MS and the ongoing MS specific treatment r iMed Beta 5 6 0q Pr Test File Edit Tools Patient ID NHS Numbe Last Name 2 First Name Birth Date 2 MS Specific Rx MS Cours Poser 2
12. Value 1 sperma Date of last visit VIVisitDate ISHPT Right 1 EDSS SVIEDSS ISHPT Left 1 ISHPT Right 2 ISHPT Left 2 PASAT Test Last Relapse Last CSF Last MRI Last EP Last Laboratory Tests Last Adverse Events Last MS Specific TT Last Symptomatic TT Last Non Pharma TT Other Patient name IDFirstName lDLastName On the left of the report text all Med information fields are available to pick as needed They are arranged according to the familiar iMed database structure see Erreur Source du renvoi introuvable To insert a field in your report drag its name from the left column into your text on the right Fields are denoted by FieldName placeholders which will be replaced by the actual patient data upon printing You can also enter these placeholders manually as long as you retain the marks around field names The Print button or menu opens a preview window showing the final report including patient data from your iMed database iMed 6 User Manual 42 amp Print Preview DAR a x iB rx 99 99 c fb dal TrmMm 7254 Close W wea FB Por Dr Kenneth Mans ell 08 07 2005 MS Clinic London UK Patient name Caroline BECKETT Date of lastvisit 01 02 2005 EDSS 3 5 When you are satisfied with your report click the Save button and simply choose a document name Your report template will be saved with your iMed database and will be available to all iMed users for printing reports
13. filename ID txt lt filename_VI gt txt filename RE txt etc These files contain data on the Patient Profile ID Visits VI Relapses RE Treatments TR Adverse Events AE and Paraclinical Tests MR CS EP LT They are linked by the Patient ID number provided by iMed in the first file e Med File med creates a proprietary Med database file that you can share with other iMed users provided that both sides use the same iMed version This file contains all the information for selected patients e XML File xml creates an XML file that incorporates the same datasets as the text file export described above You can use this file with any XML compatible software e Excel File xls creates a Microsoft Excel file that incorporates the same datasets as the text file export described above Each of those nine datasets appears in its own tab in the Excel spreadsheet In all export formats iMed only exports the list of currently displayed patients For example you can use the Search function to identify patients with certain characteristics and then export only these patient records Another way to quickly make a selection is to zoom on a column in the Statistics View 5 5 2 Importing Data The Import menu opens a dialogue box where you can choose the file name and location from where you want to import some patient data By default it starts in your local iMed installation directory Besides the name and location
14. iMed 6 User Manual 13 3 2 5 The Display Panel In the Patient record view the Display panel is the area below the Button bar where the page selected in the record Browser are displayed In the Statistics view the Display panel shows a graphical representation of the statistic selected from the Button bar 3 3 Creating a Patient Record To add a new patient into the Med database first select the Patient records view in the sidebar on the left of the screen Then click the button SIME located below the column labelled Medical records The first page of the medical record will appear in the Display panel ready for you to fill out 000000 Admin Zi T x E You must provide at least the minimum patient identification data the patient s first and last name date of birth and gender Without this information you will not be able to save the patient record Most of the patient data is optional Fill out as much of the patient profile as you wish and then click the button E sae to store the information in the database Your new patient record will appear in the patient browser iMed Quick Tip You can also press CTRL S to save the patient record iMed 6 User Manual 14 3 4 Data Organisation The Med patient record is organised in Pages logically grouped in six different Sections The d
15. record details of MRI scans such as the date of the scan the location of the scan and the number of lesions Scan Results Exam Date 26 04 2012 CNS region Brain M Ti Nb of T1 lesions Ti Gadolinium T2 Nb of T2 lesions Nb of new or enlarging lesions McDonald criteria for dissemination in space 4 O Next scheduled MRI Gadolinium administration e Yes No T1 Gd enhancing lesions 0 1 T2 hyperintensive lesions 0 lli 2113 98 94 2 Infratentorial lesions a 1 3 Juxtacortical lesions 0 1 Remarks 4 Periventricular lesions O ll1 2 3 McDonald criteria fulfilled iMed 6 User Manual 21 Based on the information you supplied Med determines automatically whether the McDonald criteria for spatial dissemination of brain lesions are fulfilled By clicking the button Y you can launch a tutorial presenting contemporary guidelines from an International Panel of experts on the diagnosis of MS and illustrated with sample MRI scans Images can be attached to each MRI scan in the tab Images To add an image from your file system click the button located at the bottom right of the screen Most common image types are supported JPG GIF PNG etc The images are copied into the Med database and shown as a new thumbnail at the bottom of the screen To delete an image select it and click the button at the bottom right of the screen Frist scan Brain scan Select an image thumbnail to display the f
16. records view in the iN New sidebar on the left of the screen Then click the button located below the column labelled Medical records The patient Identification page will appear in the Display panel ready for you to fill out 000000 Admin Y iMed automatically assigns a numerical iMed Patient ID but you can also enter your own patient code in the field Patient code for cross reference with other information systems Fields with a label in bold are mandatory others are optional You must provide at least the minimum patient identification data the patient s first and last name date of birth and gender Without this information you will not be able to save the patient record Most of the patient data is optional Fill out as much of the patient profile as you wish and then click the button to store the information in the database Your new patient record will appear in the patient browser The first page of the patient record is now completed Use the Browser to select the following pages of the patient record e Medical History Diagnosis and Notes The Medical History page allows you to document the patient s entry in your clinic and provides an overview of the patient s medical history including concomitant diseases and family disease history The Diagnosis page groups all details relevant to the patients MS diagnosis date of onset of the disease first sy
17. tab A new Safety tab is now available in the Visit page to view or edit any changes in the medical condition of the patient In particular malignancies and infections can be followed up more easily 1 2 3 New in iMed 5 4 e MusiQoL Starting from version 5 4 Med includes the MusiQoL Multiple Sclerosis International quality of life questionnaire instrument in any form of MS The MusiQoL questionnaire is a self administered multidimensional HRQoL indicator and is the iMed 6 User Manual 5 only globally specific MS HRQoL tool constructed from the MS patients perspective and the only MS specific questionnaire not adapted from a generic tool Dutch and Russian languages With the addition of the Dutch and Russian languages the Med interface is now available in 10 languages 1 2 4 New in Med 5 3 Connection with RebiSmart device The injection log stored in the RebiSmart device can be transferred to iMed The treatment compliance is calculated and displayed on the patient summary graph 1 2 5 New in iMed 5 0 New look and feel The new user interface of iMed sports a refreshed look while keeping all its usual features The new iMed sidebar allows instant access to your most frequently used features and queries Directory of Care Professionals iMed can store contact information for the care professionals involved in the care of the patients Contacts can also be imported from the standard vCard format Calendar You can no
18. to print a listing It is also possible to import one or several files at the vCard format To do so simply choose Import in the File menu and select a file at the vCard format The data imported will be displayed in the list of Care professionals iMed 6 User Manual 29 4 6 Calendar The View Calendar displays a calendar of events You can use it to schedule events visits laboratory tests etc The Patients and Caregivers stored in the other Views can be associated to the Events Events can be displayed in Calendar format by day by week or by month and in List format Use the button Q oce fa 7 12d to select the appropriate representation 012 g New o Delete iem Print April 2 4 iii Monday Tuesday Wednesday Thursday Friday Saturday DO ee m E To create a new Event press the button 7 New or simply double click on the appropriate day in the Calendar The Event window will be displayed ready for you to fill in Calendar Event Training on Rebiject From 22 05 2007 11 00 Alday event To 22 05 2007 11 30 Care Professionals involved Patients involved Jack Umul CURIE Marie 11 06 1978 mE SMITH Joe 08 02 1954 o Cancel A Save The field Category allows you to categorise the events according to your needs You can use the button ES to create your own list of Categories The butt
19. trademarks or registered trademarks of their respective companies By using this software you are agreeing to be bound by the terms of the Software License Agreement If you do not agree to the terms of this License do not use this software Please read through the Software License Agreement carefully before using iMed Disclaimer of Warranties The iMed Software is provided to User by Merck Serono SA Switzerland Merck Serono and any third parties retained by Merck Serono As Is without warranty of any kind whether express or implied written or oral including any warranty of merchantability or fitness for a particular purpose and any warranties arising out of course of dealing User expressly acknowledges and agrees that user is solely responsible for use of the software in general User assumes entire risk as to the installation accuracy and use of the software including obtention of any authorizations and consents required by User for installation and use of the software In particular Merck Serono does not warrant that installation and operation of the software will be uninterrupted or error free or that defects in software will be corrected User shall assume the entire cost of all necessary equipment hardware third party software internet access etc for the installation and use of the software including any servicing or repair arising out of or in connection with such installation or use In addition all terms and co
20. 007 05 02 2007 07 02 2007 09 02 2007 12 02 2007 14 02 2007 16 02 2007 21 02 2007 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 13 00 18 NANA ANNAN AAA A X January 2007 To 13 00 18 New dose Partial injection Partial injection Partial injection Partial injection 13 00 18 Partial injection Partial injection Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior Normal injectior March 2009 a 22 mcg 4 4 mcg 4 4 mcg 4 4 mcg 11 mcg 11 mcg 11 mcg 22 mcg 22 mcg 22 mcg 22 mcg 22 mcg 22 meg 22 mcg 22 meg 22 mcg 22 mcg 22 mcg 22 mcg 22 mcg o MME Normal injectio Y y Mi Partial injectior M Medical Records 170 DOE John 01 12 1975 DUCHOSE Marcel 12 12 1999 SMITH Joe 08 02 1954 TRUC Much 11 12 1987 TURNER Monika 20 03 1958 PA New H Delete Device Settings MEA Calendar View October 2008 82 1 December 2008 76 5 2 8 7 13 14 B EU Bar 23 24 25 27 28 New dose New cartdrige 111978 NHS Number Print Display al DELLI Sections Visits Relapses Medical Events Paraclinical Tests M Treatments J November 2008 82 2 January 2009 63 9 O 8
21. 1 2004 ad SMITH Joe 08 02 1354 Medical E vents 04 04 2003 TURNER Monika 20 03 1958 Y Treatments 05 08 2002 el NM New E Delete E Print o Cancel A Save e Basic Symptoms EDSS Scripps Quality of life Flexifields MSBase Studyfields Notes Mee Kg 5 3 2 Sharing a single Database To share an iMed database with other users the iMed database files must be installed on a shared drive over a network LAN Typically network installations are slower than stand alone installations For best performance you should run the iMed application from your local hard drive and keep the iMed database folder on the network Users with Administrator privileges can select locations of their iMed working database backup database additional resources and iMed Update downloads through the menu Tools Database Path 5 3 3 Backing Up and Restoring a Database To back up your iMed database select Backup in the Tools menu Choose a name and a location for the iMed backup file and press Save To restore data select Restore in the Tools menu Select the iMed backup file to restore and click Open This procedure will replace ALL data in your iMed database with the data from the backup database iMed 6 User Manual 35 Note it is only possible to restore a database at the same version For example it is not possible to restore a database version 4 5 in a database version 5 5 5 3 4 Data Quality Check Thro
22. 4 000351 1111111111 CURIE 11 06 1978 Rebif 44 000518 2222222222 DOE 01 12 1975 Rebif 44 l 000515 323 333 3333 DUCHOSE 12 12 1999 Rebif 22 Patient Records 000349 SMITH 08 02 1954 Rebif 44 000523 TRUC 11 12 1987 000350 TURNER 20 03 1958 Rebif 44 CDMS 41 000352 AFAHUP A 19 11 1971 Rebif 44 B hnnaea AFEMEFADOM 017428072 Dahif 291 ij Graph P Zoom rap MS course Care Gp Professionals MS course 170 patients H Calendar When patient records are selected in the upper part of the Statistics View they are also highlighted in the lower frame And vice versa Multiple selections are also possible by pressing the Ctrl key and clicking on the records in the list or on the bars in the graph 4 4 1 Selecting a Sub sets of Patients A click on a bar in the graph will automatically select the corresponding patient records For example if you are interested by the sub set of patients who have had MS for more than 30 years select the graph Duration of MS from the drop down menu then click on the bar that corresponds to gt 30 years in the lower frame The bar will now be highlighted as well as the corresponding records in the upper frame iMed 6 User Manual 21 Duration of MS 170 patients 13 7 6 0 0 0 0 0 0 lt 2 Years 2 5 Years 5 10Years 10 20 Years 20 30 Years gt 30 Years N A If you then choose to display another graph the records selected initially w
23. 444 1452 Neurostatus refers to a slightly modified version of the standardised neurological examination and assessment of Kurtzke s Functional Systems and Expanded Disability Status Scale e Safety allows you to report changes in the medical condition of the patients such as malignancies infections allergies adverse events etc e Notes can be used to enter any additional information as free form text and store pointers to relevant documents on your computer or on the Web Optionally you may display additional tabs by clicking on the tab located at the right of the last tab The optional tabs are Symptoms Scripps MusiQOL and Flexifileds Symptoms ES MusiQOL Flexifields Safety e Symptoms allows you to select all the patients symptoms at the time of the visit from a predefined list sorted by functional systems e Scripps allows you to calculate the Scripps score for the patient by adding the total number of points for each answer you have entered on this screen based on your individual assessment of a patient To obtain this score you must complete all the entries on this screen The Scripps Neurological Rating Scale is a 22 item ordinal impairment scale that converts the neurological examination with a three level scoring system with scores ranging between 100 normal and O worst The reference for Scripps is Sipe JC Knobler RL Braheny SL et al A neurologic rating scale NRS for use in multip
24. A H Hackeng Dr C P Jongkoen Dr Dalman Dr Doornenbal Dr Dalman Dr E P Walma IDr F Blom Dr F F M Blorn Dr F J M Bastiaansen Dr F OJ van der Steen Dr G Siemons Dr Kloos Dr G J de Jong Dr G J P Bloemen Dr Verheul Dr G J P Bloemen Dr Dalman Dr G M van der Weele Dr G Siemons W A van Heel Dr H van den Heuvel Dr H Ch Haverkamp Dr H P van den Heuvel Dalman Dr Horst Care Professional Function General Practitioner General Practitioner Neurologist General Practitioner General Practitioner General Practitioner General Practitioner Neurologist General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner Neurologist Ophtalmologist General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner General Practitioner Ophtalmologist General Practitioner Ophtalmologist Ophtalmologist Jack Urnul Dr Neurologist o Cancel m Save You can use the button ES to create your own list for Title Function and Location To delete an entry select the person in the list and press the button Delete The button Print allows you
25. ally detect and install new versions or corrective patches when they become available Registration Registering your copy of Med is necessary to obtain an optimal support from the Med Support Team and benefit from the new Med Update feature MS diagnosis criteria Information relevant to the MS diagnosis and disease course is now grouped in a single convenient location within iMed In addition Med determines from the information you have entered whether the Mc Donald criteria for spatial dissemination of brain lesions are fulfilled iMed also includes a tutorial presenting contemporary guidelines from an International Panel on the diagnosis of MS illustrated with sample magnetic resonance imaging scans Family history iMed now lets you record the history of MS and other diseases in each patient s family Linked documents In addition to free form notes you can add links to relevant documents on your computer or on the Web Audit trail If needed iMed can track all actions performed on the database and produce a log file for auditing purposes 1 3 About this Manual This manual is intended to provide a comprehensive overview of all the information you need to get started with iMed and to make best use of its powerful functions The chapters are designed to allow new users to understand and use iMed as quickly as possible The manual assumes that readers are comfortable using Microsoft Windows If you are new to Windows you
26. ata structure is illustrated in the tree diagram below To view or edit a patient record select the Patient the Section and finally the Page using the record Browser Medical Records Med 6 User Manual Sections Patient Profile Medical Events Paraclinical Tests Pages Identification Medical History MS Diagnosis RebiSmart Data Flexifields if defined Notes Basic Symptoms KF QD Scripps MusiQoL Safety Flexifields if defined Notes Relapses Malignancies Infections Other Medical Conditions Pregnancies Flexifields if defined CSF Evoked Potentials Laboratory Tests Flexifields if defined MS Specific Symptomatic Non Pharmacological 15 3 5 Customising Med Some aspects of Med can be customised to your particular needs Click on Edit in the menu bar then select Preferences This will display a screen that lets you change the following features of Med Center Information to modify the Center name and address the date format used for display and the paper format for printed reports If you are an Med administrator you can enable or disable the Audit trail feature see section 5 4 You can also add your Center s logo which will be incorporated in iMed generated reports Use the Add button to add an image from your file system Most common image types are supported JPG GIF PNG etc To delete the logo click the Delete button User Inf
27. cal conditions Rhinitis Malignancy Treatments Calendar Wi us specific li Symptomatic M Non pharma LI The Display panel M Relapses I Medical conditions In Paraclinical tests 0 g sh CSF gt Evoked Potentials f Laboratory tests an 4 B Adherence EDss Ut Time Scale Maximum D 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 The Sidebar Note Patient names that appear in this User Manual are totally fictitious 3 2 1 The Menu The Main Menu provides the following entries e File This menu provides data saving import export and printing options lt also allows you to exit Med e Edit This menu provides the usual clipboard functions and access to the Med Preferences see section 3 5 Customising iMed e Tools This menu provides access to advanced features including multiple user management database management data quality control audit trail and flexifields These features are only available to users with Administrator rights They are documented in section 5 Advanced Features e Help This menu provides direct access to the Med user manual and to information about your installation of iMed including the location of your database if you are logged in as an iMed administrator It also gives access to online iMed updates see section 5 1 iMed 6 User Manual 12 3 2 2 The Sidebar The Sidebar is divided in two parts The upper part contains fi
28. correct file for each of the 9 Med datasets or pages Patient ID Visits Relapses etc For each page a list of source fields is displayed on the left and a list of Med fields on the right including mandatory fields in red The assistant matches identical field names and you can re order your source fields to match the iMed import order Then please choose which fields you want to import or ignore by double clicking in the middle Relation column Once you have selected the desired fields you can save this mapping by clicking the New Template button Give it a name and you can access it directly next time you want to import data from the same source tw Med Data Import module BELLES Data in iMed are organized in Pages Please selectthe Source files containing the data you wish to import and map the Source fields to the corresponding iMed fields Page 1 9 PATIENT IDENTIFICATION Source File C Documents and Settings SM Desktop BE ID PC xls Sheet fi y Select Relation Mandatory Fields Error Checking 4 Data Import Doctor in Charge Deceased ecease Date Health Insurance gt gt gt gt gt x gt gt gt gt gt gt gt gt x x x x x x x x Stage 3 Error Checking The iMed Import Module is now ready to check for potential errors in the files to import Click the Check for Errors button and tests will be performed for each of the iMed pages that you have conf
29. d button to display the relevant medical event page e The Relapse page allows you to record information such as the date when the relapse began its duration and the affected CNS region e The Adverse Event page includes information on severity drug relationship and outcome e The Pregnancy page includes details of the pregnancy complications and birth abortion or miscarriage e f you have customised Med to add your own kind of medical event see details in section 5 3 1 Flexifields an extra button will appear in the list of tests Once you have finished entering data click the Save button Each clinical event you add is shown in the 3 column of the patient browser sorted by descending date 4 1 7 Treatments The Treatments section stores information on your patient s treatments Select the Treatments section in the patient browser and click the Add button iMed will prompt you to indicate what type of treatment you want to add Click on the desired button to display the corresponding Treatment page Several fields in this page such as the treatment name let you choose from a list of options The lists can be edited in the iMed Preferences screen see section 3 5 Customising iMed The button on the right of the list provides a shortcut to the Med Preference screen If you do not find the relevant option in the list of values click on the button You will be directed to the iMed Preference Add the n
30. dition to the dates users and reasons for changes the audit report shows the field value before and after changes By default the report displays all changes since the Audit Trail functionality was enabled You can choose to display only changes made by a particular user or select only certain actions Add Modify Delete or limit the report to a range of dates You can also sort the audit report by clicking on the desired column heading i e click on the Patient header to sort all changes by patient name in alphabetical order Click the same header again to invert the sort order By default the audit report is sorted by date and time Med 6 User Manual 37 5 5 Exporting and Importing Data The File menu gives you access to data export and import facilities 5 5 1 Exporting Data The Export menu opens a dialogue box where you can choose the file name and location where you want to export your patient data By default it starts in your local Med installation directory Besides the name and location you can choose among several export formats in the Save as type pop up list e Text File txt creates standard tab delimited text files enabling you to import the data into a statistical package or a spreadsheet Each file includes field names in the first line The character encoding is Windows Latin 1 and the date format is the one you have chosen in Med preferences From the file name you supply Med generates nine files named
31. e Every time a user saves changes from a data entry form iMed lists the fields that were modified and asks for the reason of the change Med 6 User Manual 36 Audit Trail The following data was modified Please enter a reason for changes Field Name Reason EDSS Symptoms Correcting 4 mistake Score Ambulation Correcting a mistake Copy Reason You can enter a different reason in front of each modified field or you can copy the same reason for all the changes by clicking the button Copy Reason Then click the button Save to record your changes Note that you cannot cancel your changes from the Audit panel If you have made a mistake you must first save the data then change what was wrong in the page and provide a new audit reason such as Correcting mistake The purpose of the Audit Trail is to track every action on the database 5 4 3 Displaying an Audit Report Audit reports can be viewed by administrator users via the menu Tools gt Audit Trail Audit Trail User sab Fom 01 05 2007 Action kMb v Te 28 05 2007 Y Date Time User Action Patient Section Field Before fter Reason 28 05 2007 12 07 Admin M CURIE Marie Visit 29 04 200 EDSS 45 4 Correcting a mista 28 05 2007 12 07 Admin M CURIE Marie Visit 29 04 200 Symptoms 30 20181 21 201831 Correcting a mistal 28 05 2007 12 07 Admin M X CURIE Marie Visit 29 04 200 Score Ambulati 2 1 Correcting a mistal In ad
32. elds Adding Personal Structured Information oococccoccccncocnconconcconiconos 34 5 39 2 Sharnnga single Database a a 35 5 3 3 Backing Up and Restoring a Database concconcocncocnconcocononconononeonnnanonnonancononanonnnns 35 90 2 Data Qual Check unir 36 pde AUDIT IRAI aso abia 36 541 EnabDinog the AUQIE TM id ta aede ora tectis 36 5 4 2 Providing Reasons for CHanges ccocccccncccncconoconoconocanonononanonononononanonanonanonancnannns 36 543 DISDIayIno an Audi ROO Osos ce nece ol re E de x ees tds unies tier MEME 37 5 5 EXPORTING AND IMPORTING DATA cil 38 IT EXP OMING Dal di 38 292 IMPONG AA o 38 IS IMC ANONIMO dos 39 9 6 IMED REPORTING MODULE serorei a e 42 D REBISMART DEVICE catarata aaa airs En DELE eeu 43 3 1 Hardware CONNCCHON 2 oe eb ner A AS 43 NS DTN T a T EE E 44 5 7 3 Reviewing treatment adherence data ooccooococncocnconcocononcononononnnonnonnnnancononannnnnns 44 iMed 6 User Manual 4 1 Welcome to Med 1 1 What is iMed iMed is a powerful electronic system for storing clinical data about patients with Multiple Sclerosis It allows you to manage all the important information about your patients including their medical history neurological status relapses treatments neurological rating scores on various scales and results on magnetic resonance imaging MRI cerebrospinal fluid CSF and evoked potentials tests iMed has an intuitive user interface which allows you to become immedia
33. ery The example below shows a query to find all patients with an EDSS lt 4 0 Section Page Criteria Operator Visits Basic EDSS at last visit lt AND y Y v AND v Include deleted patients in search Search in current list Last Query Clear Query Load Query Save Query Cancel Search If you wish to build a query to find patients who meet more than one search criteria select AND or OR in the first box in the second row and enter the second search criteria If needed enter a third search criteria Then press the button Search For complex queries involving more than three search criteria it is possible to run a query then run a second query based on the outcome of the first query To do so click on the checkbox Search in current list located on the right side of the Search panel before you run the second query The Search panel also includes a checkbox that allows you to Include deleted patients in search so that you can retrieve patient records that were previously deleted These records are shown in red in the patient browser You can restore a deleted patient record by clicking the Save button Four buttons appear at the bottom left of the Search panel e Last Query Press this button to recall the last query that was executed The corresponding search criteria are filled in automatically Press Search to run the query e Clear Query Press Clear query to clear the search criteria e Load Query Press th
34. ew value in the list and press the button Save The list is now updated and you can select the appropriate value in the field Once you have finished entering data on the treatment click the Save button The treatments will be listed in the 3 column of the patient Browser sorted by descending start date iMed 6 User Manual 23 4 1 8 Summary Graph When you select a patient in the patient browser a graphical representation of the patient medical history course of MS relapses visits treatments is displayed in the Display panel iMed Beta 5 5 0q Pr Test CURIE Marie 11 06 1978 NHS Number 111 111 1111 x File Edit Tools Medical Records 170 Sections Details CURIE Marie 11 06 1978 PO Patient Profile DOE John 01 12 1975 Visits DUCHOSE Marcel 12 12 1999 Relapses Patient Records SMITH Joe 08 02 1954 Medical Events TURNER Monika 20 03 1958 Paraclinical Tests TRUC Much 11 12 1987 Ed Treatments p Statistics itg New y Delete gum Print CURIE Marie Date of MS onset 15 03 1998 McDonald classification Possible MS Care Age Gender F Deceased Confirmed diagnosis 19 04 2000 Disease course RR since 12 years Professionals 111 111 1111 x Other medical conditions Rhinitis Malignancy Treatments lg us specific I Symptomatic I Non pharma Events lg Relapses Mi Medical conditions B Pregnancies Paraclinical tests e vni d CSF gt Evoked Potentials f Laboratory tests B Adhere
35. fore importing data If your database is shared on a network all iMed users should be logged out when running the iMed Import Module It is also recommended to backup your iMed database Before importing data into iMed you should export the relevant data from your other software either in plain text files or as Excel spreadsheets Imported files should have field names in their first row for easy mapping to iMed field names Also you should try to arrange the import fields in similar datasets as iMed uses Patient ID Visits Relapses Treatments etc see section 5 5 1 You will be guided through the four stages of the import process import setup data mapping error checking and data import Step 1 Import Setup Login to your iMed database choose to import from an Excel spreadsheet or a text file and select the date format and field delimiter used in your files t Med Data Import module Ey Please identify an Med database and press Login Then provide details on the file format that you wish to import Med Database Path c imed beta 4 5 database Select Login Admin Password mm 3 Data Mapping Login File Format Excel File ds Text File bt a Error Checking Text Identifier lt None gt y Date Format DD MM YYYY First data in line 2 4 Data Import Med 6 User Manual 39 Step 2 Data Mapping Select your source file s to be imported Be careful to select the
36. from within iMed see section 4 3 Printing Patient Information 5 7 RebiSmart device The injection log stored in the RebiSmart device can be transferred to iMed The adherence rate is calculated by comparing the total number of injections recorded by RebiSmart medical device during a week from Monday to Sunday with the total number of injections set per week which is three 3 The monthly adherence rate is calculated by using the weekly adherence rate to create a monthly adherence weighted average The adherence rate does not take into consideration specific days upon which injections were made The RebiSmart device settings and functions are completely independent from iMed 5 7 1 Hardware connection To connect the RebiSmart docking station 1 Take the USB cable e 2 Insert larger end with the icon facing down into the rear of the docking station iMed 6 User Manual 43 3 Insert smaller end of the cable with the into a USB port of your PC icon facing up 5 7 2 Data transfer 1 Turn on the RebiSmart device Use the buttons to navigate through the main menu to option Connection and select Open At the prompt Start computer first select OK When you see Connecting on the screen firmly place RebiSmart into the docking station 2 In iMed Got to Tools RebiSmart download RebiSmart Download Click on Next to continue Select the app
37. ges The Flexifields can be defined in iMed s four familiar sections Patient Profile Visits Paraclinical Tests and Medical Events To create a Flexifield select Flexifiels in the menu Tools then choose the appropriate Section and enter the flexifield Name and Type You can also define a Unit and a normal range In the example below a flexifield is created under the section Visits to capture the weight of the patient The field name is Weight the type is Numeric and the Unit is Kg iMed 6 User Manual 34 Flexifields Patient Profile Visits Paraclinical Tests Medical Events Field Name Flexifield Weight Numeric y Kg _ Mei Cancel A Delete Modify Cancel ru Save Text fields can contain up to 250 characters Date fields use the date format chosen in iMed preferences Fields can be reordered using the arrow buttons When flexifields are defined a new page labelled Flexifield is displayed in the corresponding Section For example the flexifields Weight defined in the previous illustration will appear in a new tab labelled Flexifields on the Visit page Medical Records 1 65 m Seclions Visits CURIE Marie 11 06 1978 a Patient Profile 23 04 2005 a DOE John 01 12 1975 A 05 04 2004 DUCHOSE Marcel 12 12 1999 Paraclinical Tests 14 0
38. igured to import If errors are detected click the Details buttons to learn what is wrong then return to stage 1 or 2 to solve the problem field separator date format data mapping or correct your import files accordingly When no errors are detected you can move on to stage 4 Med 6 User Manual 40 t Med Data Import module DEK Press Check for Errors to check for inconsistencies in the date to import J Import Setup When all data Groups are ready to import press Next Med Pages Patient Identification 3 Data Mapping 4 Data Import Stage 4 Data Import All the patients contained in your import files are listed last name first name birth date and gender and you can choose to import them all or pick only the ones you need by double clicking in the Import column Patients who seem to already exist in your Med database are highlighted in red to avoid erasing data If you choose to import them all the existing data will be replaced by the imported data When you click the final Import button a progress bar is displayed until you are alerted that the import is completed Then you can quit the iMed Import Module and launch iMed to access your newly imported data t Med Data Import module Please mark the records you wish to import and press Import i Import Setup Lines in red show patients who seem to already exist in your Med database similar LastName FirstName Birthdate and Gender
39. ill remain highlighted 4 4 2 Zooming into a Sub sets of Patients To display only a sub set of patients make a selection of records using one of the methods described in the previous section for example by clicking on a bar in the lower frame Then press the button Zom lin the button bar Following the previous example the graph would look like the illustration below Duration of MS 7 patients 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 lt 2 Years 2 5 Years 5 10 Years 10 20 Years 20 30 Years gt 30 Years N A You can also display a particular sub set of patient records using a stored query simply by clicking on the corresponding query in the Sidebar When you want to select again all the patients in the database simply click on Show all patients in the sidebar Med 6 User Manual 28 4 5 Care Professionals The View Care professional stores a directory of all persons involved in the care of the patients iMed Beta 5 6 0g Pr Te File Edit Tools Lan Statistics Care FO Professionals H Calendar Patient Records st 9 9 Ll pri do New Te Delete Print Last Name First Name A H Bogaards A L van der Wild A T Tjiam Havenzkh Blackstone Buck Kruis C A H Hackeng Dr Dalman D J Swank chirurg Dr Alberts Dr 4 3 4 Boon Erasmus M C Dr ALL v d Wild Dr A L van der Wild Dr A L van der wild Dr A W Hage Dr B Nap Dr Boonacker Dr C Bol Dr C
40. is button to display a list of previously saved queries then select the one from the list and press OK The corresponding search criteria are filled in automatically Press Search to run the query The saved queries are also listed in the Sidebar Simply click on a query in the list to execute it without even having to open the Search panel iMed 6 User Manual 25 Load Query Query ad LastName Start by A Patient Gender F Patient Gender M Mes patients avec un EDSS 2 0 Delete Cancel e Save Query For your convenience queries can be saved and reapplied at a later stage To save a query simply enter your search criteria and click the button Save Query Then type a suitable query name in the dialogue box and click OK Please note that the queries saved are also listed in the Sidebar When you wish to retrieve all the patient records simply click on Show all patients in the sidebar 4 3 Printing Patient Information Use the menu Print or the button 9 P to generate a print out The following pre defined reports can be printed e The Listing of patient records generates a listing of all patients currently selected e The Patient status report gives a summary view of the selected patient s medical history current disease status and ongoing MS specific therapy e The Summary graph provides the same information in a graphical way e The Templates choice allows you to print a custom report designed with the separate Med
41. k space At least 20 MB free disk space Display resolution At least 1024 x 768 pixels Med has also been verified to run fine on Apple Macintosh systems over virtualisation software like Parallels and VMWare 2 2 Installing iMed Before you start to install iMed we recommend that you close any other Windows applications that you are running When you are ready to install insert the iMed installation CD into your CD ROM drive To start the installation run the iMed Setup program located on the iMed CD CD ROM Drive Letter iMed60Setup exe Read the iMed Software License Agreement and click Yes Follow the instructions on the screen You have three ways to install Med 1 To start a new database select Install a new iMed 6 0 program and database and click Next In the next dialogue box you can choose between a stand alone or network installation To use iMed on a single PC select Stand alone Installation and click Next Then choose the location where iMed must be installed Toshare a database amongst several users select Network Installation and click Next Then choose a location on the PC for the iMed program and another location on the network for the iMed database files See section 5 3 to learn more on sharing an iMed database amongst several users 2 Toinstall only the iMed 6 0 program and connect to an existing version 6 0 database on your network select Install a new iMed 6 0 program only and click Next
42. le sclerosis Neurology 1984 34 1368 72 User has full and final responsibility for the analysis review and assessment of data shown including the Scripps score e MusiQoL allows you to report the patients quality of life according to the MusiQoL scale referred to in Simeoni et al Validation of the Multiple Sclerosis International Quality of Life questionnaire MusiQol study group Mult Scler 2008 Mar 14 2 219 30 e f you have customised Med to add personal structured information to the Visits section see 5 3 1 Flexifields for details an extra tab Flexifields will appear before the Notes tab Once you have finished entering data in the Visit page click the Save button All the Visits created will be listed in the Browser sorted in descending order Med 6 User Manual 20 4 1 5 Paraclinical Tests The results of the paraclinical tests should be reported in the section Paraclinical Tests Select the section Paraclinical Tests in the Browser and click the button ti iMed will prompt you to indicate what type of test result you want to report New paraclinical test Evoked Potential Laboratory Tests Cancel If you have customised Med to add your own paraclinical tests see 5 3 1 Flexifields for details an extra button Flexifields will appear in the list of tests Click on the appropriate button and the corresponding page will be displayed in the Display panel The MRI page allows you to
43. lows iMed Beta 5 6 0q Pr Test File Edit Tools MSB f A B Patient Records MUA La Statistics Med allows you to send anonymous information about selected patients to MSBase the International MS Regstry MEC GD Professionals Only idormation about patients which you choose to enroll will be sent to MSBase and identi amp c ation information such as patera name and address it never included in the data a transmitted The information is sent to MSBase using your web browser through an encrypted H Calendar Internet connection 4 Once you have sent patient information to MSDase you wil be able to benchmark your data e MSBase aganst the entire MSBase cohort or even specie sub studies You can also use the MSBase Forums to discuss your findings with other MS researchers around the word You are unable to use this feature of Med unti you have registered on ihe MSBase web ste and activated your MSBase account F you want to know more about how to join MSBase please wst www msbase org if you have already registered and actwated your MSBase account you can proceed by entenng your MSBase PIN number below Please type in your MSBase PIN On the MSBase View in iMed enter the MSBase PIN in the dedicated field and press Validate Once enabled the MSBase View should now look like this iMed 6 User Manual 31 iMed Beta 5 5 0q Pr Test File Edit Tools T Patient Records y Statistics MSBase 000351
44. may find the online help useful which you can access by pressing the Start menu on your desktop then Help There are a few conventions you should be aware of when reading this manual Text enclosed in greater and less than symbols lt gt indicates an instruction for what to type rather than the text itself For example drive letter for your CD ROM will be a single letter that your computer uses to identify the CD ROM drive Text in bold indicates a button or menu item that you must click The Mc Donald criteria for spatial dissemination of brain lesions refers to McDonald WI Compston A Edan G et al Recommended diagnostic criteria for multiple sclerosis Guidelines from the international panel on the diagnosis of multiple sclerosis Ann Neurol 2001 50 121 127 and Polman CH Reingold SC Edan G Filippi M Hartung HP Kappos L Lublin FD Metz LM McFarland HF O Connor PW Sandberg Wollheim M Thompson AJ Weinshenker BG Wolinsky JS Diagnostic criteria for multiple sclerosis 2005 revisions to the McDonald Criteria Ann Neurol 2005 Dec 58 6 840 6 iMed 6 User Manual T 2 Getting Started 2 1 Minimum System Requirements Before you try to install Med you should check that your computer meets the following minimum system requirements to enable the program to run Processor Intel Pentium or compatible Operating system Microsoft Windows NT 2000 XP Vista Seven System memory At least 32 MB RAM Hard dis
45. mptoms date of progression and MS classification according to McDonald see reference on page 6 and Poser Poser refers to Poser CM Paty DW Scheinberg L et al New diagnostic criteria for multiple sclerosis guidelines for research protocols Ann Neurol 1983 13 227 31 Med 6 User Manual 17 If you have customised Med to add personal structured information in the section Patient profile see 5 3 1 for details on the Flexifields an extra page Flexifields will appear before the page Notes The Notes page can be used to enter any additional information as free form text and also to store links to various documents on your computer or on the Web You can use the copy 8 paste functions to quickly include notes from other applications and documents 4 1 2 Deleting a Patient Record In the first column of the Browser select the patient record you wish to delete and click the button P You will be asked to confirm that you want to delete this record Please note that deleted patients are simply hidden in the database If needed it is still possible to reactivate the record To do so click on the Search button to display the Search panel Click on Include deleted patients in search and press the button Search The records retrieved will be listed in the Browser Deleted records will appear in red colour Open the patient record that you wish to reactivate and press the button Save 4 1 3 Adding Patient Data Once you have pro
46. nce EDSS Time Scale Maximum E 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Events and treatments are shown as colored horizontal bars on the chart Names of treatments are displayed inside the green bars Visits are shown as vertical red lines on the appropriate date MRI scans are shown as blue diamonds A double click on a graphical element Visit Relapse automatically opens the patient record on the corresponding page You can change the timescale of the chart using the drop down control The default choice of Maximum will set the chart to display even the oldest events visits and treatments for that particular patient You can choose other values to zoom in and out using different time scales Time Scale Maximum JU When you move your mouse over various graphical elements in the chart such as visits relapses and treatments the shape of the pointer changes to a hand Leave the pointer on the graphical element and a little pop up window will display additional details Med 6 User Manual 24 4 2 Searching the Med Database Searching the Med database is a simple process All you have to do is to enter one or more Search criteria in the Search panel To make a search press Search patients in the Sidebar The Search panel will appear Use the fields Section Page Criteria Operator and Value to build your search criteria Then press the button Search to run the qu
47. nditions of the Software License Agreement apply iMed 6 User Manual 2 Table of Contents T WELCOME TOIMED aia aladas 5 Vel NA OIM A A e de O e 5 1 2 WEHATSNEWJINIMEDY3 is 5 1 2 1 NEWTON udi euius Le LC ce M E ROI 5 LAL VIVA GRAZSURSNSEN e e ed ceda 5 mno NEW IMIM I A ETE 5 TZ N w NMO a bhatt non pete a a adi 6 1 2 5 New in iMed O Dd doliente tele dela Desi 6 120 NCWIT MM CO Do a it a Bul ae tl ee iis A M e 6 1 9 ABOUT THIS MAN AL dunt e E de n o Dd T 2 GETTING STARTED 3 nece ER Se ECL RRIENCU ES S rxET caPREpUuPUrsR Ravi sr cR ee ci E DELE e NER 8 2 1 MINIMUM SYSTEM REQUIREMENTS ccececceccceccccccceceacccecceacectaueceeesuesuscesueceenesnes 8 2 2 INSTALLING E e dear ao DO 8 2 3 STARTING IMED FOR THE FIRST TIME ccccececcececccccccecccccaccauacesceaesuesuecesueceeneaues 9 2 4 REGISTERING IED e eo 10 3 IMED BASICS iia idos 11 SL TAR IN Me a 11 3 2 THE IMED USER INTERFACE c cccceccecceccccaceccccccccececcectecceacenceneeasenceceeansneeaess 12 DEC ANA IO 12 322 AAA A 13 3 23 A Oe er oe dai 13 3 2 4 SA 13 9 259 A e ide ee ee bi dede MA M ape n MU 14 3 3 CREATING A PATIENT REGCORD uoc E ERR de CER A 14 34 IDATA ORGANISATION e red RETE 15 S5 CUSTOMISING MEDI o ME ALIM M UTC anos ES URSI 16 4 AMED STERP BY lt S 1 EP cesa Roa ERE uuu ERES sxET esaIFiCvNA PER andi e IRR M ONNX E UE E RENS 17 AS PATENT ize er BT e eo dea nO de 17 4 7 4 Creating a Patient TeCOFd a 17 4 1 2 Deleting a Patient Record
48. ntrol access to patient records depending on each user s needs In a single user installation Med installs its database on the local computer and grants all privileges to the user In a multi user setup you can define user accounts choosing among four types to grant appropriate rights and data access privileges e Administrator can read and write all patient records create new users import data backup and restore the database enable the audit trail and define flexifields e Normal user can read and write all patient records e Private user can read and write his her own patient records only e Limited user can read all patient records but not write any data The first account created during iMed installation is always an Administrator Further users can be created via the menu Tools User Management 5 3 Managing iMed Databases 5 3 1 Flexifields Adding Personal Structured Information iMed was designed by neurologists for neurologists so it can immediately handle most of the information typically required to follow up MS patients clinical condition However when iMed is your main data repository you may want to add extra fields that are relevant to your practice or your research interest Extra fields can be added either as free form text in the standard Med Notes page or as structured information using the Flexifields Flexifields are additional fields saved in the iMed database alongside the standard pa
49. on Print allows you to print the Calendar view in the actual format To export the Events select Export from the File menu and choose a file name Med will generate a file that can be open by all systems compatible with the vCal standard like MS Outlook Apple Cal Med 6 User Manual 30 4 7 MSBase Med allows you to contribute to MSBase the International MS Registry available on the internet at www msbase org Only data about patients that you choose to enrol will be sent to MSBase Personal information such as patient name and address is never included in the data transmitted Data is sent directly from Med to the MSBase web server through an encrypted Internet connection Once you have sent patient information to MSBase you will be able to benchmark your data against the entire MSBase cohort or even specific sub studies You can also use the MSBase Forums to discuss your findings with other MS researchers around the world You may only use this feature of Med after you have registered on the MSBase web site To learn more about how to join MSBase please visit www msbase org 4 7 1 Enabling data transfer capacity If your institution is registered at the MSBase Registry the Principal Investigator for your institution should have received a MSBase Personal Identification Number MSBase PIN from the MSBase Foundation Before you enable the MSBase communication feature in iMed the MSBase View should look as fol
50. ormation to modify your user name and address to specify which tabs will be displayed in the Visits section and therefore what types of information you can enter in the Visit page or to modify the language of the iMed menus and dialogue boxes There are 10 available languages Brazilian Dutch English Finnish French German Italian Portuguese Russian and Spanish Note Med will restart when you switch languages Family Relationship you can add or delete degrees of family relationship from this list Ethnic Origin you can add or delete ethnic groups from this list Medical Events and Conditions you can add or delete diseases from this list MS Specific Treatments you can add different drugs and treatment regimens to this list Symptomatic Treatments you can add different drugs and treatment regimens to this list Non Pharmacological Treatments you can add or delete treatments from this list Corticosteroid Schedules you can create your own corticosteroid schedules Care professionals you can create your own lists for Titles Functions and Locations Calendar you can create your own list for Category of event Once you have made all the changes you want click Save Your new preferences will be applied immediately iMed 6 User Manual 16 4 Med Step By Step 4 1 Patient Records 4 1 1 Creating a Patient record To add a new patient into the Med database first select the Patient
51. ropriate patient record and click on the Download Data button to confirm the data transfer RebiSmart Download 3 On the RebiSmart device At the prompt Data transfer completed select OK to close the connection 5 7 3 Reviewing treatment adherence data The effectiveness treatment for any condition is determined to a large extent by patient adherence to treatment Treatment adherence is defined as compliance or what percentage of the prescribed drug is actually taken by the patient times persistency how long a patient stays on therapy iMed allows to review injection history which includes dose date and time indicator for partial injections This can be reviewed either by a History log screen or a Calendar screen Med 6 User Manual 44 History log screen Calendar screen iMed Beta 5 5 0g Pr Test CURIE Marie 11 06 File Edit Patient Records iMed Beta File Edit Tools MusiQoL responsivenes Dg Pr Test CURIE Marie 11 Medical Records 170 DOE John 01 12 1975 DUCHOSE Marcel 12 12 1999 SMITH Joe 08 02 1954 TRUC Much 11 12 1987 TURNER Monika 20 03 1958 H Delete NHS Number IS Section Visits Relapses Medical Events Paraclinical Tests Ez Treatments fa Print PAR Injection Log Weine EET From 01 01 2007 03 01 2007 05 01 2007 08 01 2007 10 01 2007 12 01 2007 15 01 2007 17 01 2007 19 01 2007 22 01 2007 24 01 2007 26 01 2007 29 01 2
52. rticular you will be prompted to choose your iMed Username and Password Note Your Username and Password are case sensitive You will only need to enter this information when you use iMed for the first time However you will be prompted for your iMed Username and Password each time you start iMed in the future When you have finished entering the information requested click the Save button It is not mandatory to fill out all fields in this form and you can still modify the information later through the iMed Preferences When the message You registered successfully appears click the OK button iMed will start and a dialogue box will prompt you to enter your iMed Username and Password Med 6 0 Please Login Username Password Med 6 User Manual 9 2 4 Registering Med The iMed software is developed and distributed freely by Merck Serono New installations are limited to 5 patient records until an Med Licence number is entered Registering your copy of iMed gives you the right to use the software according to the terms of the Software Licence displayed at the program installation Registered users will benefit from support and can obtain new versions of iMed as they become available see 5 1 iMed Update The Registration panel will appear at each start up until your copy of iMed is registered iMed Registration This copy of iMed is not registered yet By registering your copy of iMed you will benefi
53. sername and password that you chose when you installed iMed or the username and password that were given to you by the administrator of that iMed database Once you have successfully logged in the Med application window will appear Electronic MS Patient Clinical Database If you are using your database for the first time there will be no patient record in your database and the Med patient browser will be empty You can begin adding new patient data immediately Med 6 User Manual 11 3 2 The Med User Interface The functions of the Med software are organised in five Views accessible from the Sidebar at the left of the screen Each View provides access to a different screen with specific capabilities The illustration below shows the Patient records view iMed Beta 5 6 0q Pr Test CURIE Marie 11 08 1978 NHS Number 111 111 1111 x File Edit Tools Medical Records 170 Sections Details CURIE Marie 11 06 1978 JPY Patient Profile DOE John 01 12 1975 Visits Th d B DUCHOSE Marcel 12 12 1999 Relapses Patient Records J SMITH Joe 08 02 1954 Medical Events e recor rowse r TURNER Monika 20 03 1958 Paraclinical Tests TRUC Much 11 12 1987 KA Treatments Statistics Eg New iio Delete gem Print The Button bar CURIE Marie Date of MS onset 15 03 1998 McDonald classification Possible MS Care Age Gender Confirmed diagnosis 19 04 2000 Disease course Professionals 111 111 1111 x Other medi
54. t from best support and enable useful new features like for example the ebUpdate automatically detects and installs a new version when it becomes available This reminder will disappear when the software is registered Enter your iMed software license MD BE Save To geta free iMed software license Register Now To register later and close this window Register Later If you do not wish to register at this time your copy of iMed click the button Register Later To obtain an Med licence please click the button Register Now You will be automatically directed to the online iMed registration server Fill in the Registration form and an iMed licence number will be sent to your email address When you receive your iMed Licence number please enter it in the appropriate fields in the Registration panel in iMed and click the Save button iMed 6 User Manual 10 3 Med Basics 3 1 Starting Med This section gives an overview of Med and a brief description of its main features lt also introduces the names of those features which will be used in the rest of the manual Start Med by pressing the Start button on your desktop then choosing Med from the Programs menu or simply double click the Med shortcut located on your desktop Med will start and a dialogue box will prompt you to enter your Med Username and Password Med 6 0 gt LW Please Login Username Password You should enter the u
55. tely productive In particular iMed provides interactive graphical charts which allows you to quickly analyze data on multiple patients or to drill down to the details on a specific patient iMed also provides secure multiple user support allowing you to share a single patient database between multiple users over your network It even enables you to share and benchmark anonymous patient data using the MSBase International MS Patient Registry www msbase org 1 2 What s New in iMed If you have been using a previous version of iMed you will find a number of new features in iMed which make the application even more powerful and easy to use 1 2 1 New in iMed 6 e Refreshed design Med displays now a refreshed interface The new look and feel of the program makes it even more easy and fun to use e Neurostatus You can now choose to report the FS scores and Ambulation according to the Neurostatus definitions Neurostatus provides a standardised methodology for the scoring of Kurtzke s Functional Systems and Expanded Disability Status Scale in MS e Czech and Greek languages The new Med includes two new languages Czech and Greek which can be selected individually from the Preference panel e Communication with MSBase The new Med makes it possible to upload data to your MSBase account in just one click Also you will immediately identify your list of patients enrolled in MSBase sub studies 1 2 2 New in iMed 5 5 e Safety
56. tomatically When a new version is available iMed will offer to install it the next time you start the program If you do not wish to install the new version immediately you can get on with your work and take care of the update later via the Med Update entry in the Help menu The iMed Update panel will guide you through the update process iMed Update Welcome to Med Update Current Version 5 0 0 e There is no update available Cancel After iMed has finished downloading the new version you can either install it immediately or keep it for later In that case the next time you start iMed it will remind you that the new version is ready and offer to install it If you are using iMed with a shared database the first person that installs a new iMed version will convert the database to the new format if necessary In that case other users will be warned that the database format has changed and guided to install the corresponding iMed version To ease such networked installations the new iMed installation program is ready to deploy in the same directory as the shared iMed database in a directory named Update iMed administrators can change this default location via the Tools Database Path menu Note The iMed Update feature is only available to registered copies of iMed iMed 6 User Manual 33 5 2 Managing User Accounts Med allows you to share an Med database among several users and to finely co
57. ugh the menu Tools gt Data Quality Check Med can perform a complete check of your patient database and report missing or inconsistent data The Data Quality Check window lets you display and print Errors Warnings or both Data Quality Check Display Errors and Warnings y 68 Patient Records a Type a a Comments a Metical Hito DUCHOSE Marcel 12 12 1999 T Medical History Invalid or missing diagnosis date AFAHUP 4 4 19 11 1971 T Visit EDSS missing in last visit AFEMEFADOM P 07 12 1972 T Visit FS score missing in last visit AFIMADYR T 22 10 1956 AJUTEKAK J G 08 05 1342 AKIHULUGQUTUG N N 14 08 1949 ALUKYMYT A 12 11 1358 ALUTYHUWOP M J 07 06 1958 AMUVUT L J N 05 04 1950 AMYTYLEVIL Violette 23 03 1985 APYLEJ M G 31 07 1963 Print all Print selected record Warnings relate mainly to missing or inconsistent data Errors relate to impossible data like for example a date of visit that would occur prior to the date of birth The list of Errors Warnings can be printed for easy reference 9 4 Audit Trail 5 4 1 Enabling the Audit Trail The Audit Trail functionality can be enabled by an iMed administrator via the Center Information screen on the Preferences panel 5 4 2 Providing Reasons for Changes When the Audit Trail is enabled iMed tracks all changes to the database including data modification addition and deletion the date and time the author and the reason for the chang
58. ull picture in the large viewing area above the thumbnail As you move the mouse over the large image a dotted square follows your movements to track the zoom area Click on the detail you want to view and it appears in the zoom view on the right A solid red square on the main image shows the detail location selected Move your mouse elsewhere and click again to zoom on another detail You can adjust the magnification level with a four position cursor located above the zoom view Description Brain scan LL The CSF page allows you to store details of a CSF assessment The Evoked Potentials page enables you to indicate Normal or Abnormal results for these tests The Laboratory Tests page allows you to enter values for haematology blood chemistry thyroid function immuno virology and other tests In each case you can indicate whether or not the values are outside the normal range Once you have finished entering data on the chosen paraclinical test click the Save button The paraclinical tests you reported are then listed in the 3 column of the patient Browser sorted by descending date iMed 6 User Manual 22 4 1 6 Medical Events The Medical Events section stores information on Relapses Adverse Events and Pregnancies Select the Medical Events section in the patient browser and click the Add button Med will prompt you to indicate what type of medical event you want to add Click on the desire
59. ve buttons allowing you to access the different Views e Patient records browse through the patient directory view and enter data for a specific patient e Statistics a powerful graphical view of multiple patient records e Care Professionals a directory of the persons involved in the care of the patients e Calendar a calendar of events appointments e MSBase contribute with anonymous data to the MSBase patient registry The lower part of the Sidebar contains filters or links to frequently used queries 3 2 3 The Browser The Browser is divided in three columns reflecting the organisation of the pages of the medical record see section 3 4 Data organisation Select a Patient from the list first column and use the keyboard or the mouse to move quickly between the pages of the medical record Med Quick Tip Click in the patient list and then press any key to jump to the first patient name that starts with that letter 3 2 4 The Button Bar The buttons in the Button bar are context specific i e they appear according to the needs of the View selected These buttons are used consistently throughout iMed Prints the current Adds a new entry Deletes the entry patient record o 5 New E Delete Ca Print o Cancel A Save N Saves changes that have Creates a new Deletes the patient Cancels all changes been made to the page patient record record selected that have been made to the active page
60. vided the basic Patient profile information you can use the different sections of the Patient record to document other aspects such as Visits Relapses Paraclinical tests Treatments The third column of the Browser will be empty when you click on the different Sections second column until some data is recorded in the database Medical Records 165 Sections Visits CURIE Marie 11 06 1978 4 Patient Profile DUCHOSE Marcel 12 12 1999 Paraclinical Tests SMITH Joe 08 02 1954 Medical Events TURNER Monika 20 03 1338 v Treatments N New B Delete Ca Print o Cancel m Save 4 To report new data select the appropriate Section second column in the Browser and click the button E located under the third column The process for specifying the new data will vary slightly depending on the section selected The specific steps for each section are described below 4 1 4 Visits The section Visits stores data on the neurological status of your patient at each visit Click on the button to add a new Visit to the patient record iMed 6 User Manual 18 Med 6 0 Pr Test CURIE Marie 11 06 1978 Medical Records 170 Sections MELO 74 Patient Profile DOE John 01 12 1975 its OO 20 03 2011 DUCHOSE Marcel 12 12 1999 Relapses 10 06 2009 Patient Records SMITH Joe 08 02 1954 Medical Events 29 04 2005 TURNER Monika 20 03 1958 Paraclinical Tests 09 04 2004 999 999 8888 Marie Curietoutcegenre yu Treatments 14 01 2004
61. w manage a calendar of events directly from iMed Calendars can be exported to the standard vCal format for integration with other information systems Improved search Frequently used queries are available with one click access from the sidebar Searches can be performed on all the fields as well as on your flexifields Improved MRI screen The iMed user interface for storing and viewing MRIs has been revamped Improved reporting you can now save iMed generated letters and reports in Word format as well as PDF 1 2 6 New in iMed 4 5 iMed 6 User Manual Flexifields Fields missing in iMed You can extend iMed by defining your personal fields to store additional structured information about your patients Reporting Module Create your own templates of letters and reports with your clinic details and logo e g referral letters iMed can then generate customized printouts integrating patient specific data including your flexifields Data Import module Switching to the iMed MS documentation system is made even easier through the use of an external module called iMedlmport In a few simple steps this assistant allows you to import your existing data in text or Excel format directly into an Med database Enhanced data export iMed can now export full information about selected patients including your flexifields in plain text Excel or XML Med Update To make sure that you are running the latest version Med can automatic
62. you can choose between two import formats in the Files of type popup list e EDMUS import Files txt accepts files generated by the EDMUS program version 2 5 or 2 6 European Database on Multiple Sclerosis Please read the EDMUS User Manual for details on how to export an EDMUS dataset EDMUS generates 5 export files named Idyymmdd txt Msyymmdd txt Csyymmdd txt Tryymmdd txt and Aeyymmdad txt yymmdd represents the date when these files were generated Just select any one of those files and click the Open button e Med File med accepts a proprietary Med database file generated by an Med database at the same version as described in section 5 5 1 iMed will show a progress indicator and status information as the imported patient records are added to your iMed database iMed 6 User Manual 38 Warning When importing data into iMed all patient records with the same full name birth date and gender will be replaced with the new data Med Quick Tip You may wish to backup your Med database before performing an Import operation 5 5 3 Med Import Module The Med Import Module is a separate program located in the Med installation directory by default C Program Files iMed and accessible from the Med program group The iMed Import Module allows you to import any text or Excel data into an iMed database by defining your own custom data import template Warning lt is recommended to quit iMed be

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