ABO INCOMPATIBLE KIDNEY TRANSPLANT DATA DATA DICTIONARY

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1 AUSTRALIA AND NEW ZEALAND ABO INCOMPATIBLE KIDNEY TRANSPLANT DATA DATA DICTIONARY ANZDATA REGISTRY ROYAL ADELAIDE HOSPITAL EAST WING 9 TH FLOOR NORTH TERRACE ADELAIDE 5000 JANUARY 2011

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3 3 ABO INCOMPATIBLE KIDNEY TRANSPLANT DATA JANUARY 2011 PROJECT - ABO INCOMPATIBLE KIDNEY REGISTRY DATA DICTIONARY - ABO INCOMPATIBLE KIDNEY REGISTRY PROGRAMME - ANZDATA REGISTRY DATABASE DESIGNER'S NAME - BRIAN LIVINGSTON DATE OF ISSUE - JANUARY 2011 COMPUTER - INTEL(R) - PENTIUM (R/4) - 2 GHZ OPERATING SYSTEM - WINDOWS 2000 DATABASE - ORACLE Version 9i PROGRAMMING LANGUAGE - P/L SQL, SQL *PLUS General Description of the Programme - This programme is for use by the ANZDATA REGISTRY for data entry purposes of the ABO incompatible Kidney Transplant Data through the collection of Web based Screens, and access to analysing the data through the enclosed Tables, as described in the Data Dictionary, using the Structured Query Language (SQL). An ABO incompatible graft is defined as: If Donor Blood Group = O then it is compatible and ABOi is false. For these purposes A=A1=A2. For the purposes of calculation we can recode A1 and A2 to A; A1B and A2B to AB. If donor Blood Group in ( A, A1, A2 ) and recipient Blood group not in ( A, A1, A2, AB, A1B, A2B ) then ABOi = true. If Donor Blood group = B and recipient Blood group not in ( B, AB, A1B, A2B ) then ABOi = true. If donor Blood group in ( AB, A1B, A2B ) and recipient Blood Group not in ( AB, A1B, A2B ) then ABOi = true.

4 4 CONTENTS PROGRAMME DETAILS AND DESCRIPTION 3 DATABASE TABLES ABOI PRETRANSPLANT TABLE 5 ABOI POSTTRANSPLANT TABLE 7 ABOI BIOPSY TABLE 8 ABOI FOLLOWUP TABLE 9 CD CODES TABLES AND DESCRIPTIONS 10 ABO INCOMPATIBLE PRE TRANSPLANT SCREEN 11 ABO INCOMPATIBLE POST TRANSPLANT SCREEN 12 ABO INCOMPATIBLE SUMMARY SCREEN 13

5 ABO INCOMPATIBLE KIDNEY TRANSPLANT DATA JANUARY ABOI_PRETRANSPLANT TABLE (Screen 1) Name Description Type and Size Range/Values PATIENT Patient Number (not Null) NUMBER (6) GRAFTNO Graft number (not Null) NUMBER (1) 1-5 PLASEXCH Number of Plasma Exchanges NUMBER(2) 0-20 IMMSESS Number of Immunoadsorbtion Column Sessions NUMBER(2) 0-20 TMETHOD Titres Method VARCHAR2(1) *See CDTMETHOD ANTIAPRE ANTI A pre treatment NUMBER(4) or null ANTIAAT ANTI A at transplant NUMBER(4) or null ANTIBPRE ANTI B pre treatment NUMBER(4) or null ANTIBAT ANTI B at transplant NUMBER(4) or null RITUDATE Date of first RITUXIMAB treatment DATE RITUDOSE Dose per treatment of RITUXIMAB (mg/m2) NUMBER(4,1) <1000 or null RITUNUM Number of RITUXIMAB treatments NUMBER(1) 0-4 IVIGDATE Date of IVIg treatment DATE IVIGBRAND Type of IVIg treatment VARCHAR2(1) *See CDIVIGBRAND IVIGDOSE Total Dose pre transplant of IVIG (g/kg) NUMBER(4,1) 0-20 or null SIDEEFFECT Type of Side effect VARCHAR2(1) *See CDSIDEEFFECT SIDEEFFOTH Specify Other Type of Side effect VARCHAR2(150) if side effect=o else null COMMENTS Comments VARCHAR2(150) New Table and Screen for data collection from 01-Jan-2011 (data can be backdated) * See List of Values from Reference Code Maintenance or lookup icon (if using Screen) note: RITUDATE can be up to 6 weeks prior to or on the date of transplant; and must be less than or equal to the date of death (if one). IVIGDATE can be up to 6 weeks prior to or on the date of transplant; and must be less than or equal to the date of death (if one). Monoclonal Table Data entered for the pre-transplant treatment drugs Rituximab and IVIG, is to be recorded in the MONOCLONAL table. Data to be populated for RITUXIMAB: PATIENT PATIENT GRAFTNO GRAFTNO SEQUNO need to determine the sequence number from existing dates for the graft MONODATE RITUDATE AGENT 7 AGENTOTHR null DOSES RITUNUM REASON 8 REASONOTHR ABO INCOMPATIBLE Data to be populated for IVIG: PATIENT PATIENT GRAFTNO GRAFTNO SEQUNO need to determine the sequence number from existing dates for the graft MONODATE IVIGDATE AGENT 5 AGENTOTHR IVIGBRAND DOSES 1 REASON 8 REASONOTHR "ABO INCOMPATIBLE" ABO INCOMPATIBLE KIDNEY TRANSPLANT DATA JANUARY 2011

6 6 MONOCLONAL checks It has been decided that no reverse populations are to occur. The ABOi details will be entered first as they are done in real time. During the entry of Monoclonal data for an ABOi graft, the client / server system prompts the data entry person to check the ABO interface data if any of the following scenarios are detected: if the monodate is prior to the date of transplant and agent = 5 and agentothr = a valid ivigbrand and there is no corresponding entry in the aboi_pretransplant table if the monodate is prior to the date of transplant and agent = 7 and agentothr = RITUXIMAB and there is no corresponding entry in the the aboi_pretransplant table if the monodate is on the date of transplant and agent = 5 and agentothr = a valid ivigbrand and there is no corresponding entry in the aboi_pretransplant table or the aboi_posttransplant table if the monodate after the date of transplant and agent = 5 and agentothr = a valid ivigbrand and there is no corresponding entry in the aboi_posttransplant table The data is to be corrected by adding the ABO interface details directly.

7 7 ABO INCOMPATIBLE KIDNEY TRANSPLANT DATA JANUARY 2011 ABOI_POSTTRANSPLANT TABLE Name Description Type and Size Range/Values PATIENT Patient Number (not Null) NUMBER (6) GRAFTNO Graft number (not Null) NUMBER (1) 1-5 TREATDATE Date (not Null) DATE PTTREAT Type of treatment (not Null) VARCHAR2(1) *See CDPTTREAT PTTREATOTH Specify other type of Treatment VARCHAR2(150) if treatment = 'O' or null PTDOSE Dose per treatment NUMBER(5,1) or null PTIND Type of Indication VARCHAR2(1) *See CDPTIND PTINDOTH Specify Other Type of Indication VARCHAR2(150) if indicator = 'O' or null note: TREATDATE must be on or after the date of transplant. TREATDATE must be on or before the date of death. TREATDATE must be on or before today. New Table and Screen for data collection from 01-Jan-2011 (data can be backdated) * See List of Values from Reference Code Maintenance or lookup icon (if using Screen) Monoclonal Table Data entered for the post-transplant treatment drug IVIG, is to be recorded in the MONOCLONAL table. PATIENT PATIENT GRAFTNO GRAFTNO SEQUNO need to determine the sequence number from existing dates for the graft MONODATE TREATDATE AGENT 5 AGENTOTHR "IVIG" DOSES 1 REASON 8 REASONOTHR "ABO INCOMPATIBLE" MONOCLONAL checks It has been decided that no reverse populations are to occur. The ABOi details will be entered first as they are done in real time. refer to the aboi_pretransplant table definition for full rules.

8 8 ABO INCOMPATIBLE KIDNEY TRANSPLANT DATA JANUARY 2011 ABOI_BIOPSY TABLE Name Description Type and Size Range/Values PATIENT Patient Number (not Null) NUMBER (6) GRAFTNO Graft number (not Null) NUMBER (1) 1-5 BIODATE Date (not Null) DATE > transplant date BIOPROTOCOL Protocol Biopsy VARCHAR2(1) Y, N or null BIOC4D C4d VARCHAR2(1) Y, N or null note 1: BIODATE must be on or after the date of transplant. BIODATE must be on or before the date of death. BIODATE must be on or before today. New Table and Screen for data collection from 01-Jan-2011 (data can be backdated) * See List of Values from Reference Code Maintenance or lookup icon (if using Screen)

9 9 ABO INCOMPATIBLE KIDNEY TRANSPLANT DATA JANUARY 2011 ABOI_FOLLOWUP TABLE Name Description Type and Size Range/Values PATIENT Patient Number (not Null) NUMBER (6) GRAFTNO Graft number (not Null) NUMBER (1) 1-5 PTTIME Post Transplant Treatment Time (not Null) VARCHAR2(3) *See CDTIME TITREANTIA Titres Anti A NUMBER(4) or null TITREANTIB Titres Anti B NUMBER(4) or null DRUG1 Initial of drug given VARCHAR2(1) * See CDDRUG TROUGHDRUG1 Trough concentration NUMBER(6,2) null allowed DRUG2 Initial of drug given VARCHAR2(1) * See CDDRUG TROUGHDRUG2 Trough concentration NUMBER(6,2) null allowed DRUG3 Initial of drug given VARCHAR2(1) * See CDDRUG TROUGHDRUG3 Trough concentration NUMBER(6,2) null allowed URINEACR urine Albumin/Creatinine Ratio (mg/mmol) NUMBER(6,2) or null alert if > 100 New Table and Screen for data collection from 01-Jan-2011 (data can be backdated) * See List of Values from Reference Code Maintenance or lookup icon (if using Screen) note 1: The "Daily Tacrolimus Dose" is stored on the DRUG table with drug code "V" and is not to be entered via the ABO interface screens. note 2: Initially only 1 drug is to be recorded. This is Tacrolimus (code V)

10 10 ABO INCOMPATIBLE KIDNEY TRANSPLANT CODE TABLES JANUARY 2011 CDIVIGBRAND TABLE Name Null? Type CODE Not Null VARCHAR2 (1) TEXT Not Null VARCHAR2 (50) CDPTIND TABLE Name Null? Type CODE Not Null VARCHAR2 (1) TEXT Not Null VARCHAR2 (50) CDPTTREAT TABLE Name Null? Type CODE Not Null VARCHAR2 (1) TEXT Not Null VARCHAR2 (50) CDSIDEEFFECTTABLE Name Null? Type CODE Not Null VARCHAR2 (1) TEXT Not Null VARCHAR2 (50) CDTIME TABLE Name Null? Type CODE Not Null VARCHAR2 (3) TEXT Not Null VARCHAR2 (50) SORT_ORDER Null NUMBER(2) CDTMETHOD TABLE Name Null? Type CODE Not Null VARCHAR2 (1) TEXT Not Null VARCHAR2 (50) These Tables may be accessed and printed through the SQL query facility EXAMPLE: (Type in) (For CDTMETHOD Table) SELECT CODE,TEXT FROM CDTMETHOD

11 11 ABO Incompatible Pre Transplant Treatments Screen

12 12 ABO Incompatible Post Transplant Treatments Screen.

13 13 ABO Incompatible Summary Screen

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