1. Index Introduction User Interface Designer Information Technical Information Click on any subject … … or let the presentation continue with...

2. Index

3. genericProMISe is a generic tool to Design and Manage single/multi center clinical research projects (both registrations and prospective trials) Information is stored and retrieved using the Internet Explorer browser over a (secure) internet connection The Designer (study coordinator) manages the entire project (design as well as logistics) All projects can be dynamically changed and extended during their life cycle, incorporating new scientific developments are the need for more in-depth information

4. Index The number of studies (projects) is unlimited Studies are implemented at the Dpt of Medical Statistics of the Leiden University Medical Center (current version; the next version allows for design via Internet) Data are stored in a relational data base system in SQL-Server Tools are included to maintain the structure of the project, the data bases, log files and user access authorization tables

5. Index Each center has access to its own data (in full detail) and to the combined data of all centers (descriptive statistics only) The entire project is placed on a WEB server and access is managed by the WEB part of ProMISe The internet connections are protected by the Server’s security mechanisms

6. Index The user enters and retrieves data using the Internet Explorer (5.5/6) WEB browser only ProMISe contains a set of dynamic HTML forms, computed in real time and automatically reflecting the underlying structure of the project and any user preferences Only one software copy exists on a server and any updates take effect immediately in all projects and all centers

7. Index The same copy of the software is used for any number of data entry/retrieval projects No programming is involved in the design and maintenance of a project: data bases with structural information are continuously queried to generate the user interface dynamically Software improvements/additions created for one project become available to all users of all projects instantaneously!

8. Index Development of an entire Internet data management system is reduced to hours or days of (clinical) specifications instead of months or even years of programming labor All aspects of the electronic CRF’s can be modified during the study without jeopardizing the integrity of the data Additional (sub)studies or clinical trials can be integrated with very little effort

9. Index ProMISe can also be used as an information retrieval-only system for centers while data are being entered in the central study center The ProMISe system can co-exist with any other data management system The system uses an open architecture; runs on Windows NT/2000 Server + SQL-server + IIS Web Server Organisations can independently build their own websites which can display data interactively requested from a protected ProMISe project (for example statistical data for patient information sites)

10. Index Any clinical study that can be conducted using standard paper Case Report Forms (CRF’s), can also be realized within the ProMISe framework Since only standard SQL-Server tables are used, already existing data can be converted to ProMISe easily after creating the appropriate structure Users can download their own private MS-Access data bases or Excel files for local data analysis or connection to other local data base systems

11. Index ProMISe is in production now for over 2 years in over 500 hospitals in Europe Some of the Current Projects: *Blood and Marrow Transplantation data in Europe 195 hospitals entered >10.000 transplant over the past 2 years totalling now 150.000 transplants and 300.000 follow-up records *Dutch Knee Society 11 departments of Orthopaedics running a permanent registry on knee-related data *Study registration in chronic leukemia in Europe All currently going-on analyses in the CLWP available to all member- researchers *Clinical trials in Bone Marrow Transplantation Several multi-country trials in CLL and CML *European registry on Neutropenia *European registry on Neutropenia (under development) *Clinical trial in the Netherlands on leukocyte depletion *Clinical trial on transfusion triggers in orthopaedic surgery *DEMO PROJECTS ON HIP, KNEE AND SHOULDER ARTHROPLASTY FOR THE NERASS GROUP

12. Index DEMO PROJECTS ON HIP, KNEE AND SHOULDER ARTHROPLASTY FOR THE NERASS GROUPDEMO PROJECTS ON HIP, KNEE AND SHOULDER ARTHROPLASTY FOR THE NERASS GROUP The projects represent the core of a much larger clinical dictionary for the registration of hip, shoulder, knee, wrist and ankle prosthesis research data The purpose is to start with a pan-European, small yet fully extendable research data set where contributing members also have full statistical access to the complete data base A scientific committee should advise about the items actually collected by all participants Statistical multi or single center analyses will be part of such a European registration project

13. Index Introduction User Interface Designer Information Technical Information Click on any subject … … or let the presentation continue with...

14. Index Examples drawn from 3 specific registry projects in orthopaedic surgery

15. Index the Home page of the study center should contain a link to the list of available projects A link to all projects supported by your organization

16. Index When multiple projects are run by the same organization, a WEB page will have to list them for easy access by the users This is the last page created manually: all other WEB pages are generated in real time by the ProMISe software Click on the link of the project you want to start

17. Index A typical page contains *a button to access the PRIVATE data base for each center *a button to access the COMMON data base (for information on all centers together) *a button to TEST the hard and software for compatibility with ProMISe Click here to obtain anonymous info on all study data Choose your own private data base from the pick list....... and press the button to start your session. TEST your configuration before using ProMISe for the 1st time!

18. Index National Views can be enabled by the study coordinator Authorized users will be able to retrieve data on ALL centers within one country ProMISe automatically creates in this way a National Registry for each participating country! Click here if you are authorized to obtain information on a national level

19. IndexTabulations: data listingsdata listings CRF printoutsCRF printouts frequency tablesfrequency tables missing datamissing data survival analysissurvival analysis Enter or modify the data stored in your Private data base Determine which items you actually want to see To change to another center or to the COMMON file All other programs Close session

20. Index Initially you see the frequency distribution of an item........ which you can change into any other item from your data base with the pick list...

21. Index... to see its frequency distribution.

22. Index Tabulation *condensed overviews *columnar listings of data *status-like overviews *frequency tables and crosstabs *missing data reports *survival analyses At any time during a session you can press one of the TABULATE buttons to obtain these kind of reports.

23. Index To obtain any report, you must.... *choose the items to appear in the report *the type of layout you want *press the RECALCULATE button... or... *choose from a list of reports prepared for you by the Designer of your project To the left you see a column with all currently available items...... in which you can simply select one or more items to appear in a report. Choose the TYPE of data list you want to see...... and press the Calculate! button

24. Index A condensed list is actually an overview of all Unique Identification Codes (called UIC’s) in your data base These UIC’s provide you with a link to the actual data 60 patients currently in the data base

25. Index each line in such a report represents one item from the data base all information on a single UIC is listed on the screen when follow-up forms are present, all of them are retrieved at once You can change the layout in various ways

26. Index Just experiment by choosing from the options at the top of the screen! Here values and labels are merged into 1 column to save space

27. Index each column now represents one item each line corresponds to an individual observation *a line may correspond to a UIC *a line may also correspond to one particular follow-up record Mark all items you want to appear in the report as a column...... choose the columnar structure...... and press the Calculate! button

28. Index Want to know the distribution of Gender? Click here...

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30. Choose any of the 5 tabulation types and the screen will adapt itself to allow you to specify the contents of the report

31. Index ProMISe supports both one-way and two-way tables One-way tables can be displayed graphically Choose the items for which you want to count the codes Choose the type of table Tables and graphics?... and press the Calculate! button

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33. ... and choose 1 item from the pick list; then press the Calculate! button again For a cross tabulation of 2 items, first change the structure...

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35. More options are available, e.g. *applying logical restrictions *sorting of output To select UIC’s choose a free SLOT....... click on the item to be considered...... and specify a restriction for example: ‘equals 1’

36. Index Use of summary statistics (means etc.) in the tables Automatically treat ‘dates’ as ‘time-elapsed-since...’ Influence presentation of multiple response items Make the tables link-sensitive Click on any category in a frequency table (or cross tabulation) to instantly obtain a list of all patients belonging to that category (or combination of categories) Replace Dates by ‘Time- elapsed since another date’ Replace counts by a summary of a 3rd item

37. Index Currently 3 types are implemented: *missing data reports: a listing of all UIC’s on which at least one of the items chosen by you, are missing *survival analysis reports (K-M and COX) *Log file reports Choose the correct layout WebpageWebpage Filled paper coding formFilled paper coding form Excel spreadsheetExcel spreadsheet MS-Access data baseMS-Access data base... and press the Calculate! button

38. Index Each item still missing is clearly marked A UIC is listed only when at least one of the items checked is missing

39. Index Your session was started with a ‘default’ selection of items, in this project called ‘OPERATION’. Other selections may be pre-programmed by your study coordinator or you can define them yourself

40. Index The Designer determines with which selection you always start You can switch to any other collection (just think of another paper coding form with partially overlapping information) at any time in any report or during data entry

41. Index To start Data Entry on your CRF, press this button Some buttons change their meaning All UIC’s in your data base are loaded into a list from which you can choose All Follow-Up forms belonging to the current UIC are also loaded

42. Index The current values (obtained form the data base on the server) are automatically filled on the CRF The CRF is divided into blocks of related information by the Designer

43. Index Just pick a UIC from the list...... And press the LOAD BUTTON

44. Index Click for a new UIC (patient or transplant) Coding system and Help Description of item Current value Label of current value

45. Index Click on any item you want to edit Extensive help available whenever useful IMPORTANT you should complete each new value by pressing the ‘Tab’ key only in that way will the cursor ‘jump’ to the next item automatically

46. IndexIMPORTANT this counter display the number of modifications not yet saved in your data base in other words: the number of values that differ between your screen (local) and the data base (server) Press this button whenever you want to SAVE your modifications to disk in your Private data base A list of modifications to be executed appears. Press ‘Confirm’ to execute...

47. Index Click here to obtain an up-to-date overview of this item from your data base

48. Index ProMISe maintains the address tables of all participating centers The tables are kept up-to-date by your project Designer Choose SHOW ADDRESSES

49. Index You can choose between Registries and Centers (if applicable) You can choose between condensed and complete addresses You can count how many UIC’s each center contributes to the COMMON file Just move the mouse over the link to see the details projected at the top of the page

50. Index Downloading has a 2-fold purpose! *It provides you with a BACKUP of your private data base *It enables you to analyze your data locally and possibly merge your data with a MS-Access database in your own center! Choose Download from the Main Menu Then fill in this form and press the DOIT NOW button

51. Index Downloading uses the functionality of your browser Always use the RIGHT mouse button for downloading Click with your right mouse button on the link and then choose option ‘Save as...’

52. Index The downloaded data base contains some utilities for your convenience *automatic conversion to.DBF files *automatic creation of SPSS-WIN source files to convert your data, including all variable labels, value labels, missing values etc. to a SPSS system file Press to convert all data to.DBF files Press to write a complete SPSS setup for you

53. Index Your MS-Access Private Data Base contains *your actual data *all relevant information from the Dictionary for a correct interpretation of the values in your data base Patient- operation table Follow -Up

54. Index The current Dictionary (the meaning of all items and codes in your project) is always available to you *all items *all value labels *all quality tests and warnings *all jumps which determine what the ‘next’ item is when you press the Tab key in Data Entry ChooseDictionary on the Main Menu

55. Index Item s Click on ‘Label’..... scree n move s to labels

56. Index Always finish your session correctly to bring the administration on the Server up-to-date! Do NOT close your session by closing the BrowserMaster Window... … but click on ‘EXIT’... … and then either finish the session or download a backup copy first.

57. Index Introduction User Interface Designer Information Technical Information Click on any subject … … or let the presentation continue with...

58. Index

59. In the current version, the DESIGN of each project is maintained by the foundation IMSOR which is a cooperation between the Dpt of Medical Statistics and the Dpt of Orthopaedics of the LUMC In the next version it will be possible that others contribute to the Design of these projects also via Internet

60. Index Introduction User Interface Designer Information Technical Information Click on any subject … … or let the presentation continue with...

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62. Every project has its own data base Access protection via WEB Server (secure, encrypted connections) Access to individual data at center level Statistical access to data of all centers together Items can be protected against statistical evaluation

63. Index Microsoft IIS secure server under Win2000 advanced server with Thawte Security Signature Server maintained by Dpt. of Med.Statistics, Leiden University Medical Center User access authorization at Server level (password and IP-address)

64. Index Software level authorization by Project coordinator *level 1: user can obtain statistical information not relating/identifying patient, physicians, centers or countries *level 2: user can list individual patient data but no modification allowed *level 3: user may modify data *level 4: user may also download a copy of the private data base Access to the COMMON file will not exceed level 1 under any circumstances

65. Index All access via Internet (secure connections) IE 5.5 or higher required (others will not work) No local software needed Software minimizes data traffic over Internet at the expense of heavy use of the local PC in terms of processor load and memory requirements

66. Index All centers must acquire authorization on official hospital paper with the central project coordinator Data Entry is disabled unless explicitely requested and allowed by study coordinator Although backups are made by the Server Administrator, centers are ultimately responsible for downloading their private.MDB file as a BACKUP at regular intervals

67. Index Currently Win2000, 4000 Mb memory, 4 CPU’s, 3*32 Gigabyte RAID-controller HTML generating ISAPI DLL by Heitml, Germany Interactive Graphics by Netcharts

68. Index Users can interactively verify requirements at startup time Minimally equipped PC: *233Mhz, 64Mb memory, IE5.5, 1024*768 resolution, true color (16-bit), 56K modem connection “Work as if local & no delay” -equipped PC: * 600Mhz, 256Mb memory, IE5.5, 1024*768, true color, permanent internet connection

69. Index Introduction User Interface Designer Information Technical Information Click on any subject … … or let the presentation continue with...