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1. Please only report Country of Birth A Unknown Country of current residence D Unknow deceased patients if this Sex Female Male Unknown is requ ired by your Death before initial registration centre Familial Case Unknown Twin No Yes identical Yes non identical Yes but heredity unknown Unknown Consanguinity of parents No Yes Probable Unknown Documenting Centre Test Centre After you have successfully created the patient entry the standard patient tabs are shown see 2 6 2 5 Veryifing an imported patient In order to verify an existing entry click on the entry in the list You are then asked to confirm that the patient is still alive This does not apply for deceased patient entries transferred from another registry page 8 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual Contirm Patient Living Status Please select Is this patient still alive WI Yes No Unknown OK Cancel verification process lf the patient was still alive at the last time you heard of him select Yes You can enter the time point of last news later on in the Current status form 2 6 2 This also means that If the last time you saw him was a long time ago e g two or three years but your center still follows this patient select Yes lf the last time you saw him was a long time ago e g more than three years and your center does NOT follow him anymore select No This is because you
2. 10 3 grams milliliters These two values are calculated and stored by the system lf you enter BOTH mg kg dose and absolute dose the system calculcates whether the two match If not a dialog box is shown as follows Current brand name Current route of administration a urrent place of administration Patient s current weight Current dose amp no close x The absolute dose does not match the dose in mg kg The calculated value is 143 mg kg Take calculated and save Take yours and save Return to form If you enter the dose in milliliters the brand name is needed for the calculation because each brand has a specific IgG concentration Subcuvia Baxter l Unknown Subcutaneous Intramuscular Unknown Home Hospital Hospital inpatient Hospital outpatie 35 kg Unknown 294 mg kg body weight Dose per month 365 100 grams milliliters Current dose total amount x page 17 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 Deceased patients lf you are a working on an imported entry of a deceased patient or b have selected Death before initial registration for a new patient the Patient tabs look slightly different Death info Way to Diagnosis PID Diagnosis Therapy info Additional tab for information on the date No current status but Therapy info for HSCT and and cause s of death gene therapy
3. City of residence 24DA42 e g The Eyrie Please also enter zip Postal code City Se a oe code and place of Add patient residence as well as maiden name if This service is operated by ESID Online Registry coordination CCI University Medical Center Freiburg Tel 49 Mainzeliste Copyright 2013 2015 Martin Lablans Andreas Borg and Frank Uckert Licensed under the GNU Affero General Public License AGPLv3 More avail able in order to make your entry duplicate proof After you have added the data select Add patient and the system will take you back to the main server lf the patient has not been registered before there will be a message in the top row saying Create Patient Patient Consent Full consent Research only Date of birth Year 2015 Month 4 lf the patient exists and has been registered at your centre the message will say lf the entry belongs to another centre you are redirected to your patient list and there is a message that tells you the name of the center that this patient belongs to page 26 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 9 3 Edit personal information sometimes you realize that part of the personal information is incorrect e g e The patient has married and changed his her family name e There is a typo in the entry You can then edit the personal information by selecting the p
4. Current PID Diagnosis field to select a PID diagnosis Next you will be asked to confirm the clinical diagnosis criteria as described in the verification process 2 5 page 13 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual Genetic laboratories There is a field that asks for the name of the Lab that performed the genetic analysis You can select one of the names from the list and see the details for the lab by clicking on the question mark if you want to make sure that this entry is correct Lab that performed the genetic analysis Paris CEDI Name of lab unknown Sequencing method x O Ge tic isis 7E Lab Details An di Reason for genetic analysis x gt pj Name Paris CEDI Full Name Study center of primary immunodeficiencies Centre d tude des d ficits immunitaires CEDI Save Reset Add new entry Contact Person Capucine Picard Contact Email capucine picard inserm fr Country France OK page 14 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 6 4 Current status Patient Way to Diagnosis and PID Diagnosis only have to be completed once at the first documentation baseline documentation The Current Status form has to be completed at every documentation timepoint This is what the Current Status form looks like at baseline Create Current Status Date of last news from patient This is the date of the last cl
5. e lf you have not completed a field or entered inconsistent data messages are displayed on top of the page A The field Sex cannot be empty Please enter or select a value 4 Please enter a value for the field Country of Birth Create Patient Patient Consent Full consent Research only Not applicable deceased Date of birth Year 2000 Month Country of Birth Fr i Sex DlMale 2 Female 2 Unknown 2 1 1 Two types of unknown Since version 1 6 the ESID Registry offers two fields to indicate that information for an item is not available Currently unk Truly unk These have been introduced to enable the documenting centres to differentiate between items that they currently dont have at hand but may be able to enter it later after further investigation and items where data is really not available not matter how hard they look Before this was introduced there was only one option unknown which did not offer this possibility So please note the following Definitions Currently unk This means that you do not have the data at hand at the moment but if you ask the treating physician or go trough the patient files in detail you may find and enter it later Truly unk This means that data is really not available and in effect you should waste no more time looking for it All previously entered unknown items have been converted to currently unknown when switching to version 1 6 March 13 20
6. 1 2015 07 0 No No Yes Yes Yes Yes E Page 1 of 1 15 ad View 1 2 0f2 For all registered patients until the end of version 1 7 2015 07 13 the ICF version has been set to unknown so that datasets are still evaluated to complete page 12 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual Please note that you can select from all consent forms that have ever been in use at your centre The consent forms are each distinct and follow this pattern Language Version number Version date ethics committee EC that approved this form If a version is missing please send an email to us we will add it for you 2 6 3 PID Diagnosis In the PID Diagnosis form it is possible to enter a diagnosis with known or unknown genetic defect e Known genetic defect You can either select a clinical diagnosis Current PID diagnosis and the possible genes for this diagnosis are displayed Current Pid Diagnosis Current PID diagnosis Severe combined immunodeficiency SCID Affected gene 7 v Search Pid by Gene Additional genes Genetic tests performed x Not genetically tested Save Reset CD3z CD45 Coronin 1A OR you can first enter the gene and then select a suitable PID diagnosis SEL SLE o gt Hide Search 0 RAG1 E Atypical Severe Combined Immunodeficiency Atypical SCID Omenn syndrome severe combined immunodeficiency SCID e Unknown genetic defect Use the
7. Save button below every form e Some centres use a personalized version of the system i e they can work with patient names The additional features of this version are described in 2 9 e Buttons with a question mark 5 contain definitions for all fields where necessary e The system contains classic drop down menus as well as searchable auto complete fields The latter are marked by a magnifier like this To use this type of field 1 Enter two or more characters 2 Wait until a list of matching entries is displayed and select one of these e Date fields o Fields that ask for a complete date contain a date picker that appears upon selection of the field 201 2 04 16 No visit since last d g April 2012 D Su Mo Tu We Th Fr Sa L 2 3 5 G T a 10 14 2 13 14 g 15 EG 17 18 19 20 21 23 22 24 25 26 27 28 29 30 o Date fields that are split into three fields Year 2004 Month 11 Day 16 Here it is possible to leave month and day open Please only enter the date as precisely as known Do not use dates like 2000 1 1 or 2000 15 6 to signal that month and day are unknown This only leads to flaws in data quality page 4 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual e Some fields only appear after you have selected a specific field e g Familial Case 7 Yes No Unknown Familial Case Index patient ndex patient is the patient s
8. T Subject Your message Upload attachment max 2MB Datei ausw hlen Keine ausgew hlt Send message Reset You can reach us also by telephone 49 0 761 270 78171 or by FAX 49 0 761 270 36960 Contact address Benjamin Gathmann Centrum Chronische Immundefizienz CCl Engesserstr 4 D 79108 Freiburg Germany Contact details University Medical Center Freiburg Center for Chronic Immunodeficiency CCl Engesser Str 4 79108 Freiburg Germany Tel 49 761 270 78171 Email esid registry uniklinik freiburg de page 29 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 4 Registry FAQ This manual does not answer all possible questions A good starting point for questions not answered here are our FAQ which you may find here http esid org content download 13670 386342 file Registry FAQ pdf page 30 of 30
9. of Birth Living Status alive deceased Sex PID Diagnosis Gene Last date of docu The date of the last documentation timepoint Date of last news The date that the most recent documentation is based on as entered in form Current status e Level 1 Complete Yes if level 1 was completed at the last date of docu Each column can be used to sort or filter the list e g All patients a ESID ID 4 Year of Birth Living Status PID D agnosis Gene Last Date Of Docu Date of Last News Level 1 Complete x x All x Bir v ie CVID x x x x All Y x 30000 2000 4 poi CARDS deficiency CARD9 2014 06 04 Yes 30926 2003 Deceased scp IL7Ralpha 2014 05 13 2014 05 01 Yes Lost to follow sp 0927 2004 A Discharged after complete recovery Shwachman Diamond syndr SBDS 2014 04 30 2012 04 16 No 0928 1998 A Female Agammaglobulinemia 2014 04 30 2014 04 22 No 30930 2000 Alive Female Combined ID PNP 2014 04 29 2014 04 01 Yes 30931 006 Alive Male Congenital neutropenia 2014 05 02 2012 06 11 No 30933 2000 Alive Female CVID 2014 04 29 2014 04 08 No 30934 1996 A Male Unclassified IDs 2014 05 05 No 30936 200 Alive Male Combined ID LIG4 2014 05 05 2014 05 01 Yes 309338 2002 Alive Female CVID 2014 05 05 2014 02 05 No 30940 200 Alive Female CVID 2014 06 04 2014 04 01 No 0944 2001 Alive Male ALPS 2014 04 29 2014 04 01 No 30952 1994 Alive Male CSR HIGM Hyper lgM UNG 2014 05 02 2014 05 01 No 0955 2001 Alive Fema
10. the respective entry is added to the ICD10 section Underlying cause currently unkn Underlying cause truly unkn ICD 10 categorisation optional ICD10 Code List Click on a row to edit data or add a new entry Add New ICD10 Code ICD10 Text Nig Unspecified kidney failure cd Page 4 of 1 15 lf an option is de selected the system will ask if the corresponding ICD10 entry shall be removed A Please Confirm Do you want to remove the responding 1CD10 Code N19 Yes No Of course you can also add and edit ICD10 codes manually You can also delete them by selecting an entry and then click the Delete button Edit ICD10 Edit ICD10 Code of Death Cause Code A N19 Text Unspecified kidney failure Save Reset page 19 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 8 Follow up documentation lf you have completed a documentation timepoint for a patient it is possible to add a follow up documentation The system will start sending email reminders if a patient has not been updated for more than one year 365 days In any case you can enter follow ups as often as you like but only one per day Please note though that only one documentation timepoint is possible per day This also implies that you cannot enter baseline data and follow up data on the same day because the documentation date is automatically generated and stored by the system This is an example f
11. 15 page 5 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 2 Accessing the system Enter the following URL in your browser https cci a1 ukl uni freiburg de EERS e The new ESID Registry System HELP v Login Username Password Login Forgot your login or password Enter the login credentials you received from the ESID Registry team When you log in for the first time you will be asked to change your password A Sorry your password has expired Please create anew one Create new Password Username test cc Click on this lock to Current Password 7 display the password New Password fi as Clear text Repeat new Password Generate password Sos LeSS Optional Click this button to let the system generate a The new password has to have at least 1 upper case letter 1 lower case letter 1 digit 1 special character of this list _ and has to be between 6 and 16 characters long In case you have trouble logging in you find our contact details in the HELP menu top right page 6 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 3 The main page patient list After logging in the system shows a list of your patients This is the view that the system also returns to if you click Select patient in the top left corner The following columns are displayed ESID ID The unique patient ID Year
12. CAUSES x2 32hsied sid tether eee laSiidasiad iasisttanee 18 2 6 Folow Up GOCGUMENTAUON sssersesseereersrer sir tar sin rae nisar EEEE SEAE ESROS ii 20 281 Ghanging the PID diagnosis arenesan 21 2 8 2 Loading previous data for lg replaceMent cceeeeceeeeeeeeeeeeeeeeneeees 23 2 9 Personalized version cccccceecccececeseceececeeseeeeeececeeeseueeseeseeetaueeseeeseeesaneess 24 291 Patent isSt WINNINGS cerie 24 2 9 1 1 Improving the loading time ccccceccseeeceeeeeseeseeeseeeeeeeeseeeseeeens 24 2 9 1 2 Downloading the patient list with NAMES cceeeeeeeeeseeeeeeeeenees 25 295R SOng and Er oee E 25 29 2 Greate a new Palenlensxtawia aE a A E E maa 25 2 9 3 Edit personal information ccccccccsecceeecsecceeeceeeceueeeeeesseeseueenaeenaees 27 2 9 4 Add personal information to existing patient cccccccseeeseeeeseeeeeeeees 27 210 ACCOUN SONG Srsracartcenntens pucetus ie teunteud E EEEE E 28 3 Contacting the Registry adMINistrator cccccccccseececeeeeeceeeeeeeeeeesseeeeseeeeesaeees 29 A REOSE AC oxgausosacuensosssusesatonssavsseaucuneseseeuesiusmaueeiusaesnecysansuesynasmnosssasunocusaeevesense 30 page 2 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 1 Introduction Welcome to the ESID Online Registry for Primary Immunodeficiencies This web based database system allows you to enter and access patient data in a secure decentral
13. Change Password Centre National German Registry F Title First name Idat Last name User Gender sex Female Male Unknown e These contact details Email esid registry uniklinik freiburg de dis diced ty he ESD Alternative email address Registry team to Mics contact you e g send Fax number you a new password invite you to join a neice study etc Postal code If use the Ta personalized version you Country of living D can set the default patient list behavior here as well Affiliation for publications as the caching method Display names in list s eee ee Cache patient list locally s Patient List size 100 Define a standard Language English number of patient App Theme Theme cupertino entries per page in the Display animation F patient list in info dialogs page 28 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 3 Contacting the Registry administrator For contacting us you can either send an email or call us details see below or you can use the contact form inside the Registry which is available in the HELP menu User Benjamin Gathmann Centre Test Centre 25 4 until Auto Logout Account Settings HELP v Weg eee ny Contact E Manual J Level 1 Complete Verified ha As you can see this manual itself is also available in the HELP section Use the contact form below or write an email directly to esid registry kenes com Get In contact Topic
14. ESID Online Registry for Primary Immunodeficiency Diseases User Manual co ESID Online Registry User Manual provided by oY ss Center for Chronic 4 seize Immunodeficiency www uniklinik freiburg de cci htm Version 1 8 2015 07 13 page 1 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual Table of contents 1 MTPOGUE TION 232 415 seesaw rersciou n A ai arisa ras rr mrii 3 2 Working with the Database SYSt M cccccceececseeceseeeeeseeesseeeesaeseesaeeeseeeeeeas 3 2k General OMNCIO CS renean o reesteacctea antennas o e a a 4 2 1 1 Two types Of UNKNOWN ccccccceecceeeceeeeceeeceeeceeecseeseeeseueenseeseeeseeens 5 Zaz ACCC SSMO SV SIS Mine 6 2 The manpage patientis salessJecetsalesedte yest esas bie sadee seen tieelesedie ilar adiea ede 7 24 Addn a TVG WOU SINE aac scalars Reape detente daha ledge eda dddnPedaaddeedeteateee 8 2 5 Veryifing an Imported Patient cccceecccsececseeeceececeucecsuceceusecsusessueessusensees 8 2 6 LNG allem AOS 2a hee a ee ea ea ee a 11 ZO Pauen dsceiadernced eceteacbcepagebatedayeheteharenaseed aa ehated O Y 12 20 2 GORSEALUIGE aaa aa a aes 12 20 9 HANDED IAG INOS IS eaters arent nea aren cu ane uacugan sen oesakaruns ahaa Gace eons eeinsuaneoas 13 204 Curent o tatUS soeone ieee EEOAE EEUE ONE UES EEES 15 20 NGS DIAC SINGIN cenis EEE EAEEREN 16 27 DECCESEd palenie xcesweseceve ene aeie EA 18 24 WD TO COGING GE AlNr
15. Please note that no follow ups can be entered for deceased patients Previous entries for lg replacement remain stored Data on HSCT and gene therapy can still be entered 2 1 ICD10 coding death causes The Death info tab contains an additional section for ICD10 codes This section is in contrast to all other items in the Registry optional It was added because some centres need this categorization for internal purposes In order to simplify the adding of ICD10 codes corresponding codes for the Main cause of death are suggested by the system when one of these options is selected Main cause s ofdeath Septic shock Heart failure Respiratory failure Liver failure Renal failure Multiple organ failure Haemorrhage Thrombosis Neurological complications surgical complications Drug toxicity Relapse of malignancy Veno occlusive disorder Gratt versus host Disease Rej Ei l a LHai i E D ger Other main factor A Please Confirm Main factor currently unk Do you want to add the corresponding ICD 10 Code N19 Main factor truly unk Underlying morbid setting s associ 2 Infection E Malignancy Immune dysregulation Transplantation related cause Other underlying cause Underlying cause currently unkn Underlying cause truly unkn ICD 10 categorisation optional Code 7 5 Text 7 5 page 18 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual If confirmed
16. ased Date of birth Year 1975 Month 6 Country of Birth Netherlands C Unknown Country of current residence A Netherlands E Unknown Sex Female Male Unknown Familial Case No Yes Unknown Twin No Yes identical Yes non identical Yes but heredity unknown Unknown Consanguinity of parents No Yes Probable Unknown Documenting Centre Test Centre Save Reset 2 6 The Patient tabs The patient tabs are the standard view for a patient There is a header row that shows the patient s unique ID the year of birth and current age as well as the currently selected Documentation date ESID ID 32 Year of birth 2001 Age 14 Doc date 2015 07 13 Consent Way to Diagnosis PID Diagnosis Current Status Check complete Flag not complete The tabs themselves carry checks and flags that signal whether the form has already been completed lf you are editing a patient that has been imported some forms may already contain data but the forms are not marked as complete because selections are missing for some items In order to complete a patient please select every tab marked by a flag and enter the necessary data page 11 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual The Documentation date which is shown on the top right cannot be edited manually lt is the time point when the patient was created or verified see 2 5 and i
17. atient and clicking on the Edit IDAT name button in the Patient tab More than one index patient Twin No Ye Consanguinity of parents No Ye Documenting Centre Dresden Univi Save Reset Edit IDAT name This results in a redirect to the other server where you can edit all of the data Edit patient Personal data First name s Willi Last name Wonne Birth name if different Date of birth 2014 04 01 City of residence Wonnhalde Postal code City Save When you are finished Save takes you back to the standard view Patient tabs 2 9 4 Add personal information to existing patient lt may happen that some of your patients have been registered without names e g because you recently switched to the personalized version In these cases you can add the IDAT by clicking on the following button in the Patient tab Le OT Pa GUT Yy Ol Pare ribs 7 Documenting Centre Add IDAT name 1 IDAT is short for the technical term identifying data page 27 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 10 Account settings You can edit your account and change your password by clicking the link on the top right of the screen User Benjamin Gathmann Centre Freiburg 2 Childrens Hospital P 29 36 until Auto Logout al Account Settings HELP See en Edit user data Usemame idat Change Password
18. duplicate entries For the second task it is important that you really enter as many details as possible and not only the patient names page 25 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual Enter personal data for a new patient Information This web application manages and stores identifying patient data IDAT for the ESID Registry consisting of the fields below It uses the data entered in these fields to find possible matches in the current list of entries After you have submitted the data below your web browser will return to the main server pages In case of a direct match you will be redirected to the matching entry in case this patient belongs to your centre Please make sure to read the messages displayed after returning to the main server a If first or last name consist of multiple components enter all components separated by spaces or hyphens in the appropriate field In case of compound names check if they are written as one word like Annalena or separated Anna Lena a Enter the birth name only if it differs from the last name The fields marked with are mandatory x Currently the following non ASCII special characters are supported i N A R Personal data First name s e g Sansa Last name e g Lannister if different i _ Birth name e g Stark Date of birth YYYY MM DD
19. e Female Male Female Female tlale Farmals ESID Online Registry for Primary Immunodeficiency Diseases User Manual time that you load the patient list it will not be faster because then the cache is being generated On all subsequent loads the loading time should be faster 2 9 1 2 Downloading the patient list with names You can also download the patient list with names using the button below the list Export CSW Currently only CSV format is available Depending on your browser you will need to save and rename the downloaded file to a csv file In order to open it with Excel please use the Excel text import function Please make sure to set the CHARSET in the Excel import settings to UTF 8 otherwise special characters like Umlauts will not be displayed correctly 2 9 1 3 Sorting and filters Please note that the sorting and filters that you set and save on the patient list WITH names is NOT visible in the patient list WITHOUT names and vice versa This means that in fact you can save two sets of filters 2 9 2 Create a new patient lf you create a new patient the system redirects you to the other server in order to enter the patient name etc screenshots next page This other server has two purposes 1 It stores the patient name complete date of birth and place of residence so this data can be loaded into the ESID Registry 2 It performs a so called record linkage and thereby prevents reporting of
20. ent PID diagnosis D Affected gene Search PID by Gene Additional genes Genetic tests performed x Yes but no mutation found Not genetically tested Result pending History of genetic tests unknown Save Reset Previous diagnosis entries are displayed as a list below the current diagnosis Current Pid Diagnosis Current PID diagnosis CARDS deficiency Affected gene CARDS vy Search Pid by Gene Additional genes Date of genetic diagnosis Year 2009 Month Day Date unknown a a a Samay cena Panna does Sequencing method xi Gene sequencing Whole exome genome sequencing Unknown Lab that performed the genetic analysis London GOSH v Name of lab unknown Save Reset Pid Diagnosis List of former diagnoses Current PID diagnosis Affected gene Additional genes Diagnosis valid from Diagnosis valid until Unclassified syndromic immunodeficiencies 2014 04 23 2014 06 04 a Page 1 of 1 15 View 1 1 of 1 Export CSV EXCEL ODS PDF RTF XML Documentation timepoint Documentation timepoint when the former diagnosis when a new diagnosis was was entered entered instead page 22 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 8 2 Loading previous data for lg replacement In order to minimize the documentation burden you can load the Ig replacement data from the previous documentation timepoint into the form Create lg Replacement Current bra
21. entry is selected Alive Deceased Lost to follow up Discharged after complete recovery Changes to diagnosis No change is pre selected No Change FID diagnosis has changed No PID after all Therapy items Current lg replacement Yes No Unknown Haematopoietic stem cell transplantation HSCT Yes No Unknown Gene therapy le Yes No Unknown You need to change HSCT and gene therapy only if it was No or Unknown previously because the previous selection is already displayed so Yes remains Yes and does not have to be selected again at every documentation Please also note that all HSCT and gene therapies are only entered once and can be edited at every documentation timepoint 2 8 1 Changing the PID diagnosis lf you have found a genetic mutation in your patient you can simply enter this into the PID diagnosis However if the clinical diagnosis PID Diagnosis has changed this has to be documented as a new diagnosis entry in order to preserve the previous data Patient Way to Diagnosis PID Diagnosis Curren Current Fid Diagnosis Current PID diagnosis A Unclassified synd Affected gene Additional genes Genetic tests performed x Yes but no mutati Lab that performed tha cenetcanalysis 7 Newcastle Save Reset Add new eny page 21 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual New Pid Diagnosis Create PID Diagnosis Curr
22. inical visit last news phone letter etc unknown Current lg replacement Yes WNo Unknown HSCT Yes No Unknown SCETIDEID EBMT ID Gene therapy Yes No Unknown Please note the following e You must enter a date of last visit of the patient at your centre or the date of last news from the patient This is important to know which timepoint the reported data refers to e If you select lg replacement an additional tab form appears e The same is valid for HSCT and Gene therapy HSCT Gene therapy Patient Way to Diagnosis PID Diagnosis Current Status fe Ig Replacement Fdit Current Status Date of last news from patient 7 7014 04 11 This is the date of the last clinical visit last news phone letter etc unknown Current lg replacement Yes No Unknown HSCT Yes No Unknown SCETIDE ID dfw3 EBMT ID grtrfcge Gene therapy Yes No Unknown Save Reset Additional forms page 15 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 6 5 Ig replacement The form for immunoglobulin replacement includes many automatic checks as well as Calculations in order to ensure that data is entered complete and correct Some of these features are described here e Only appropriate routes are shown for each brand Current brand name T Unknown Current route of administration Intravenous Subcutaneous In
23. ized way through the internet via your own browser This manual includes a detailed guide to the documentation process All pages in the system include detailed descriptions tool tips and other explanations Therefore most of the features should be self explanatory With this manual we mainly want to describe the general documentation process and those features which are probably not completely intuitive The ESID Registry project is managed at the Center for Chronic Immunodeficiency at University Medical Center Freiburg Current project leader Dr Nizar Mahlaoui Chairman ESID Registry Working Party Project coordination Dr Gerhard Kindle Benjamin Gathmann 2 Working with the Database System Before we start this tour we would like to remind you that you are working with real patient data Therefore please observe the following user principles e every user of the system every user name corresponds to one person only e never log into the system with someone else s user name e close the session by logging out after finishing your work e keep your password in a secure place e use a secure password e change your password regularly page 3 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 1 General principles e Please make a selection for every field this is necessary in all forms of the Registry if not stated otherwise e To save the data you must click the Create or
24. le Shwachman Diamond syndr SBDS 2014 05 12 2014 05 01 No 30956 1999 Alive Female Shwachman Diamond syndr SBDS 2014 05 12 No Page 1 of 46 p gt p l 15 v View 1 15 of 682 Saving your sorting and filters lf you would like to save your current filters so that the list is loaded the same way the next time you call it you can do so using the buttons on the left top side of the list All patients ESI Reset all sorting and filter values Save the current sorting and filters page 7 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual The list can be exported in different formats using the buttons displayed below the list Export CSV EXCEL ODS PDF RIF AML By default the list shows 15 entries per page You can set a personal default value of up to 100 entries in your account settings 2 10 For users who enter data for more than one center an additional column Documenting Centre is visible in the patient list 2 4 Adding a new patient In order to add a new patient select New patient on the top left of the page Select patient a New patient All patients ESID ID Documenting Cent Ext The following page shows up Please enter the details for the patient Explanations for the fields are available via the buttons Create Patient Patient Consent Full consent Research only Not applicable deceased Date of birth Year Month
25. markers at least 2 of the following SFASL gt 200pq ml Vitamin B12 gt 1500ng L IL 10 gt 20pq ml impaired FAS mediated apoptosis Does the patient fulfil the diagnostic criteria for this disease Yes No Unknown For patients with lymphoproliferation and or autoimmunity who do not fulfil these criteria please consider the foll OK Cancel registration process The underlying process is depicted here eee Data transfer and verification by users Show dialogue als patients still alive a he data xyz do not match the diagnostic criteria Please verify that the diagnosis is correct Clinical diagnosis with consistent data e g lab values Clinical diagnosis with available criteria nies 2 Show dae Rd eae als patients still alive genae s Paton entry Does the patient fulfil the veritas yof diagnostic criteria for this disease Entry is verified User enters diagnosis details page 10 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual If you have successfully verified the entry the patient tabs are shown for further editing see 2 6 ESID ID 31004 Diagnosis CGD Year of birth 1975 Age 40 Doc date 2015 02 42 Patient entry verified Date of first documentation set to 2015 02 12 Way to Diagnosis PID Diagnosis Current Status Edit Patient Patient Consent Full consent Research only Not applicable dece
26. nd name Current route of administration Current place of administration Patient s current weight Current dose Current dose total amount x Dose unknown Interval for this dose Interval unknown Current side effects Save Reset Load previous data O Subcut _ Home kg a L Select inte E U Yes Create lg Replacement Current brand name 7 Current route of administration Current place of administration Patient s current weight Current dose Current dose total amount x Dose unknown Interval for this dose x Flebogamma 10 Grifols O Unknown Intravenous Unknown i Home Hospital Hospital inpatient Hospital oul 55 kg Unknown 91 mg kg body weight Dose per month 1274 5 grams milliliters 3 Select interval type first every x weeks or days x time s every 2 J weeks days Please also note that the date of the very first lg replacement is only requested at the baseline documentation Date of first lg replacement Year Month Day page 23 of 30 Date unknown ESID Online Registry for Primary Immunodeficiency Diseases User Manual 2 9 Personalized version lf your centre uses the personalized version i e patient names are included there are additional features 2 9 1 Patient list with names In the patient list you can display patients names You can enable this feature by clicking
27. nserted automatically by the system some of the tabs forms are described in detail in the following chapters 2 6 1 Patient lf you select Yes for familial case you can select the ID of the index patient for this family if he she has been registered The index patient is the first patient diagnosed with this immunodeficiency in this family If you link several patients in this way you are able to switch between patients belonging to this family by clicking on show family list Familial Case No Yes Unknown Index patient 2 show family list Index patient is the patient s grandson daughter 7 This is the index patient i List of relatives x Click an a row to switch to this patient ESID ID Year of Birth Status Sex Is index Index rel PID ClinDx year GeneticDx year o pa 1973 Alive Female Yes 1995 3 2010 Alive Female No grandson daughte Agammaglobulinem 2012 2014 rea Page of 1 15 wew 1 2 of 2 Export CSV EXCEL ODS PDF RIF XML 2 6 2 Consent ICF Since version 1 8 the system requests detailed information on the ICF informed consent form that the patient has signed Note that you can add several consent forms for a patient like here Patient Way to Diagnosis PID Diagnosis Current Status Consent List Click on a row to edit data or add a new entry Add New 6 Date of signature Consent version Version unknown Research Option Pharma Option 2015 07 02 Dutch version 1
28. on Show pei des All patients Show patient name ESID ID Documenting Centre Year of Birth Living Status xX Teszi xX x All T X 30000 Test Centre 2000 Alive 309285 Test Centre 2003 Alive H427 Test Centre 2004 Alive 30928 Test Centre 1998 Alwe 30930 Test Centre 2000 Alwe 30931 Test Centre 2006 Alwe La Tact antra Hini A Inra Please note that if your centre has a large number of patients it may take up to 15 seconds to load the patients names because the personal patient data is stored on another server and loaded into the page Therefore you can switch between Show patient names and Hide patient names as you like You can also set a default value for this feature in the Account settings 2 7 The patients name is always displayed on top of the page independent of the patient list setting A Select patient G New patient CEREDIH admin Peter Hans ESID ID 3 Year of birth 2014 Age 0 Documentation date 2014 04 30 2 9 1 1 Improving the loading time In your account settings see 3 1 you can define that your complete patient list will be saved locally on your computer Note that first name last name and complete birth date will NOT be saved but this caching method still reduces the loading time for the patient list with names considerably especially if you have more than 1000 patient entries Please also note that after you have activated this feature the first page 24 of 30 All Femal
29. or a complete documentation timepoint e All tabs have a check sign e Follow up is displayed next to the current documentation date ESID ID 30936 Year of birth 2002 Age 12 Documentation date 2014 04 29 Followup Way to Diagnosis PID Diagnosis Current Status Ig Replacement HSCT Gene therapy The following dialog box is shown Add Follow Up x Add follow up documentation for this patient OK Cancel Next the patient tabs are shown and the Current Status form is selected Patient Way to Diagnosis PID Diagnosis HSCT Y Gene therapy Create Current Status Date of last news from patient No news from patient since last documentation This is the date of the last clinical visit last news phone letter etc unknown Current status Alive Deceased Lost to follow up Discharged after complete recover Changes to diagnosis No Change PID diagnosis has changed No PID after all Current lg replacement Yes No Unknown HSCT Yes No Unknown SCETIDEID 3 dfw3 EBMT Gene therapy Yes No Unknown Save Reset page 20 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual As you can see all other tabs do NOT have to be documented again except for Ig replacement Only the following items require documentation Date of last news from patient or alternatively the date of last news from the patient Current status the previous
30. should only register patients currently followed by your center lf you Know that the patient is now followed by another center and this is an ESID Registry Documenting Center please send us an email with the patient ID We can arrange a transfer of this entry to the other center then If you select No the entry will be deleted from the system This is because the system is not intended for retrospective documentation of deceased patients The system asks you for confirmation before the entry is deleted A no close x Only alive patients can be imported to the registry As you have chosen No this patient entry will be deleted from the registry If you are not sure about the living status go back and select Unknown so you can return to this patient again later Continue Back to previous form Next depending on the type of diagnosis the system asks you to confirm or change the diagnosis e g page 9 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual Confirm clinical criteria Please select The clinical criteria for Autoimmune lymphoproliferative syndrome ALPS are At least one of the following splenomegaly lymphadenopathy gt 3 nodes gt 3 months non infectious non malignant autoimmune cytopenia gt 2 lineages history of lymphoma affected family member AND at least one of the following TCRab CD3 CD4 CD8 of CD3 T cells gt 6 elevated bio
31. tramuscular Current brand name Hizentra CSL Behring 7 Current route of administration Subcutaneous Intramuscular Current brand name Endobulin Grifols T Current route of administration intravenous e Automatic calculation of dose This read only value is Enter mg kg OR absolute l y value Icul f dose OR BOTH calculated from dose amp interval amp weight Patient s current weight kg Unknown Current dose mg kg body weight Dose per month Current dose total amount x grams milliliters Dose unknown E Interval for this dose Select interval type first every x weeks or days x time s per week month or year Interval unknown E The interval can be entered in two different formats please select one of these for each entry every weeks days time s per week month year page 16 of 30 ESID Online Registry for Primary Immunodeficiency Diseases User Manual Example of automatic calculation Patient s current weight Current dose Current dose total amount x Dose unknown Interval for this dose Patient s current weight Current dose Current dose total amount x The weight is needed to calculate the mg kg dose kg JUnknown mg kg body weight grams Dose per month 10 3 m Select interval type first every x weeks or days milliliters every5 weeks days 35 kg JUnknown 294 mg kg body weight Dose per month 235

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