Persons using assistive technology may not be able to fully access information in this file. For assistance, e-mail niddk-cr@imsweb.com. Include the Web site and filename in your message. NIDDK Liver Transplantation Database LONG-TERM FOLLOW-UP FORM CLINICAL & LABORATORY DATA 2/10/2000 Version 4.0 FORM KEYS COMPLETION LOG DCCID Data Collector ID______ - __________ Patient ID ________ - __________________ ID Center Initials Evaluation Timepoint _______ E TMPT (ETMPT) Data Collection Date _____/_____/_____ DCCM/DCCD/DCCY MM DD YY FOR CLINICAL CENTER USE ONLY LT Entry Date: ___/___/___ LX Entry Date: ___/___/___ LB Entry Date: ___/___/___ MM DD YY **************************************************************************************************************** LONG-TERM FOLLOW-UP FORM NIDDK Liver Transplantation Database PATIENT ID _________-_______________ ID To be completed by the clinical coordinator at yearly follow-up, or at time of death or retransplantation. If the patient was retransplanted or died since the last follow-up evaluation during the operational phase of the LTD (June 30, 1995), this follow-up evaluation should be completed to capture information up to the time of retransplantation or death. I. 1. EVALUATION TIMEPOINT (check one): ETMPT (ETMPT) __ 1.1 Initial follow-up __ 1.2 Year 2 follow-up __ 1.3 Year 3 follow-up __ 1.4 Year 4 follow-up __ 1.5 Retransplantation Date of Retx: ___/___/___ EPOM EPOD EPOY (complete PP, PG forms) __ 1.6 Death Date of Death: ___/___/___ (complete MD, PP, PG forms) MM DD YY (pathology forms if possible) 2. Is there any new information on this patient since the last evaluation? Yes___ No ___ NEWIN (YN) 2.1 IF NO give reason (e.g. lost to follow-up) __________________________________ NOINF (30 char) DO NOT PROCEED WITH THE REST OF THIS FORM 3. METHOD OF EVALUATION (check all that apply): (YN) MTIP __ 3.1 Telephone interview - patient MTIO __ 3.2 Telephone interview - other: specify relationship to patient __________________________ MTIOS (30 char) MCV __ 3.3 Clinic visit MCH __ 3.4 Current hospitalization (YN) MMC __ 3.5 Medical chart MCPTR __ 3.6 Computer database MNURS __ 3.7 Nursing dictation MOTH __ 3.8 Other, specify __________________________________________ MOTHS (30 char) 4. Date of latest contact/information during this evaluation period: ___/___/___ LCM LCD LCY MM DD YY 5. PATIENT STATUS (at time of evaluation or most recent): DATE 5.1 Karnofsky scale (use codes on opposite page)____ KAR (KARNO) ___/___/___ KARM KARD KARY HGTCM 5.2 Height _____ cm ___ ins x 2.54 ___/___/___ HGTM HGTD HGTY WGTKG 5.3 Weight _____ kg ___ lbs ( 2.2 ___/___/___ WGTM WGTD WGTY 5.4 Blood pressure SYS _______/ DIA ________ ___/___/___ BPM BPD BPY Systolic/diastolic MM DD YY 5.5 Is the patient currently on hypertension medication? Yes ___ No ___ HYPRM (YN) 6. EVER DRINK ALCOHOL since last follow-up evaluation? Yes ___ No ___ Unk ___ HXD (YNU) IF YES 6.1 Currently drink? Yes ___ No ___ CD (YN) IF YES Number of drinks during a typical week ____ DWK IF NO When did patient last drink? ____/____ SDM/SDY MM / YY 6.2 Has patient ever thought or been told that he/she may have a drinking problem? Yes ___ No ___ Unk ___ TDRIP (YNU) 7. Number of BIOPSIES done at this evaluation or since the last evaluation: BXN _____ (enter 0 if none). Dates of Biopsies: 7.1 ___/___/___ BX1M BX1D BX1Y 7.5 ___/___/___ BX5M BX5D BX5Y 7.2 ___/___/___ BX2M BX2D BX2Y 7.6 ___/___/___ BX6M BX6D BX6Y 7.3 ___/___/___ BX3M BX3D BX3Y 7.7 ___/___/___ BX7M BX7D BX7Y 7.4 ___/___/___ BX4M BX4D BX4Y 7.8 ___/___/___ BX8M BX8D BX8Y MM DD YY MM DD YY _______ BXM (YN) Check here if additional biopsies, and document in COMMENTS section. Use the keywords MORE BIOP to precede the comments. 8. Number of CHOLANGIOGRAMS done at this evaluation or since the last evaluation: CHLN _____ (enter 0 if none). Dates of Cholangiograms: 8.1 ___/___/___ CHL1M CHL1D CHL1Y 8.5 ___/___/___ CHL5M CHL5D CHL5Y 8.2 ___/___/___ CHL2M CHL2D CHL2Y 8.6 ___/___/___ CHL6M CHL6D CHL6Y 8.3 ___/___/___ CHL3M CHL3D CHL3Y 8.7 ___/___/___ CHL7M CHL7D CHL7Y 8.4 ___/___/___ CHL4M CHL4D CHL4Y 8.8 ___/___/___ CHL8M CHL8D CHL8Y _____ CHLM (YN) Check here if additional cholangiograms, and document in COMMENTS section. Use the keywords MORE CHOL to precede the comments. 9. Number of ULTRASOUNDS done at this evaluation or since the last evaluation: USN _____ (enter 0 if none). Dates of Ultrasounds: 9.1 ___/___/___ US1M US1D US1Y 9.5 ___/___/___ US5M US5D US5Y 9.2 ___/___/___ US2M US2D US2Y 9.6 ___/___/___ US6M US6D US6Y 9.3 ___/___/___ US3M US3D US3Y 9.7 ___/___/___ US7M US7D US7Y 9.4 ___/___/___ US4M US4D US4Y 9.8 ___/___/___ US8M US8D US8Y MM DD YY MM DD YY _____ USM (YN) Check here if additional ultrasounds, and document in COMMENTS section. Use the keywords MORE ULTRA to precede the comments. II. Number of HOSPITALIZATIONS since last evaluation: HOSPN _____ (enter 0 if none). (Note: Include only those that lasted at least three days or terminated in death) Provide information for each hospitalization: Admission |Days |Discharge |Reason(s) for Hospitalization |Other, specify (30 char) Date |IN |Date |Check all that apply | (MM/DD/YY) |ICU |(MM/DD/YY) |(see codes below) (YN) | ________________________________________________________________________________________________________________ HA1M HA1D HA1Y NICU1 HD1M HD1D HD1Y HRFU1 HRRD1 HRAR1 HRCR1 HRI1 HRRX1 HRO1 HROS1 1. ___/___/___ ______ ___/___/___ 1__ 2__ 3__ 4__ 5__ 6__ 7__ ____________________ HA2M HA2D HA2Y NICU2 HD2M HD2D HD2Y HRFU2 HRRD2 HRAR2 HRCR2 HRI2 HRRX2 HRO2 HROS2 2. ___/___/___ ______ ___/___/___ 1__ 2__ 3__ 4__ 5__ 6__ 7__ ____________________ HA3M HA3D HA3Y NICU3 HD3M HD3D HD3Y HRFU3 HRRD3 HRAR3 HRCR3 HRI3 HRRX3 HRO3 HROS3 3. ___/___/___ ______ ___/___/___ 1__ 2__ 3__ 4__ 5__ 6__ 7__ ____________________ HA4M HA4D HA4Y NICU4 HD4M HD4D HD4Y HRFU4 HRRD4 HRAR4 HRCR4 HRI4 HRRX4 HRO4 HROS4 4. ___/___/___ ______ ___/___/___ 1__ 2__ 3__ 4__ 5__ 6__ 7__ ____________________ HA5M HA5D HA5Y NICU5 HD5M HD5D HD5Y HRFU5 HRRD5 HRAR5 HRCR5 HRI5 HRRX5 HRO5 HROS5 5. ___/___/___ ______ ___/___/___ 1__ 2__ 3__ 4__ 5__ 6__ 7__ ____________________ HA6M HA6D HA6Y NICU6 HD6M HD6D HD6Y HRFU6 HRRD6 HRAR6 HRCR6 HRI6 HRRX6 HRO6 HROS6 6. ___/___/___ ______ ___/___/___ 1__ 2__ 3__ 4__ 5__ 6__ 7__ ____________________ HA7M HA7D HA7Y NICU7 HD7M HD7D HD7Y HRFU7 HRRD7 HRAR7 HRCR7 HRI7 HRRX7 HRO7 HROS7 7. ___/___/___ ______ ___/___/___ 1__ 2__ 3__ 4__ 5__ 6__ 7__ ____________________ HA8M HA8D HA8Y NICU8 HD8M HD8D HD8Y HRFU8 HRRD8 HRAR8 HRCR8 HRI8 HRRX8 HRO8 HROS8 8. ___/___/___ ______ ___/___/___ 1__ 2__ 3__ 4__ 5__ 6__ 7__ ____________________ HOSPM (YN) _______ Check here if additional hospitalizations, and document in COMMENTS section. Use the keywords MORE HOSP to precede the comments. Reason(s) for Hospitalization 1. Follow-up evaluation 2. Recurrent disease 3. Acute rejection 4. Chronic rejection 5. Infection 6. Retransplantation 7. Other, specify III. MEDICATIONS given during this evaluation period. (Note: Only those medications listed on opposite page are to be included.) For each medication given during this evaluation period, provide the code (from list on opposite page), name, date that medication was started, and code for reason medication was given. If the medication was discontinued during this evaluation period, record the date of termination and reason. If the medication was continued from the previous evaluation, record "NA" in the space for START DATE. If the medication is continuing at the time of evaluation, record ”NA” in the space for STOP DATE. If reason for initiation or termination of medication is not provided in the list, record code for OTHER, and specify reason. Med. Medication name INITIATION TERMINATION Code (30 char) Start Date Reason IF OTHER, specify Stop Date Reason IF OTHER, specify (MM/DD/YY) (code) (30 char) (MM/DD/YY) (code) (30 char) (MEDCHG) (MEDCHG) IMMUNOSUPPRESSANTS IM1 IMN1 IMS1M IMS1D IMS1Y IMR1 IMRS1 IMT1M IMT1D IMT1Y IMTR1 IMTS1 1. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ IM2 IMN2 IMS2M IMS2D IMS2Y IMR2 IMRS2 IMT2M IMT2D IMT2Y IMTR2 IMTS2 2. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ IM3 IMN3 IMS3M IMS3D IMS3Y IMR3 IMRS3 IMT3M IMT3D IMT3Y IMTR3 IMTS3 3. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ IM4 IMN4 IMS4M IMS4D IMS4Y IMR4 IMRS4 IMT4M IMT4D IMT4Y IMTR4 IMTS4 4. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ IM5 IMN5 IMS5M IMS5D IMS5Y IMR5 IMRS5 IMT5M IMT5D IMT5Y IMTR5 IMTS5 5. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ IM6 IMN6 IMS6M IMS6D IMS6Y IMR6 IMRS6 IMT6M IMT6D IMT6Y IMTR6 IMTS6 6. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ IM7 IMN7 IMS7M IMS7D IMS7Y IMR7 IMRS7 IMT7M IMT7D IMT7Y IMTR7 IMTS7 7. ____ ___________________ ___/___/___ _____ ____________________ ___/___/___ _____ ________________ IM8 IMN8 IMS8M IMS8D IMS8Y IMR8 IMRS8 IMT8M IMT8D IMT8Y IMTR8 IMTS8 8. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ OTHER MEDICATIONS M1 MN1 MS1M MS1D MS1Y MR1 MRS1 MT1M MT1D MT1Y MTR1 MTS1 1. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ M2 MN2 MS2M MS2D MS2Y MR2 MRS2 MT2M MT2D MT2Y MTR2 MTS2 2. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ M3 MN3 MS3M MS3D MS3Y MR3 MRS3 MT3M MT3D MT3Y MTR3 MTS3 3. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ M4 MN4 MS4M MS4D MS4Y MR4 MRS4 MT4M MT4D MT4Y MTR4 MTS4 4. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ M5 MN5 MS5M MS5D MS5Y MR5 MRS5 MT5M MT5D MT5Y MTR5 MTS5 5. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ M6 MN6 MS6M MS6D MS6Y MR6 MRS6 MT6M MT6D MT6Y MTR6 MTS6 6. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ M7 MN7 MS7M MS7D MS7Y MR7 MRS7 MT7M MT7D MT7Y MTR7 MTS7 7. ____ ___________________ ___/___/___ _____ ____________________ ___/___/___ _____ ________________ M8 MN8 MS8M MS8D MS8Y MR8 MRS8 MT8M MT8D MT8Y MTR8 MTS8 8. ____ ___________________ ___/___/___ _____ __________________ ___/___/___ _____ ________________ MMORE (YN) _______ Check here if additional medications from list, and document in COMMENTS section. Use the keywords MORE MEDS to precede the comments. IV. GRAFT DYSFUNCTION requiring diagnostic or therapeutic intervention since last evaluation. Number of causes: GRDFN ____ (enter 0 if none). Provide the information for each cause of dysfunction, using the codes provided for underlying cause and outcome/current status. Specify as required. Cause |If neoplasm, biopsy,|Cont.from| Onset |How was dysfunction determined? |Recur. | Outcome |If resolved, (code)| complic. or other, |prev.eval| Date | (check all that confirmed |disease|/current|reLT, or died | specify(30 char) |(check if|MM/DD/YY)| enter ND if not done) | (check| status|Date | | Yes) | | (YNND) |if yes)| (code)|(MM/DD/YY) (GDCAUS) (YN) Bioch|Histol|Serol|Radiol|Clinical|Toxicol (STCODE) _______________________________________________________________________________________________________________________ 2.GDC2| GDS2 | GDP2| GD2M/GD2D/GD2Y| GDBI2| GDHI2| GDSE2|GDRA2|GDCL2|GDTO2 |GDRC2 |GDSC2 |GDR2M/GDR2D/GDR2Y 3.GDC3| GDS3 | GDP3| GD3M/GD3D/GD3Y| GDBI3| GDHI3| GDSE3|GDRA3|GDCL3|GDTO3 |GDRC3 |GDSC3 |GDR3M/GDR3D/GDR3Y 4.GDC4| GDS4 | GDP4| GD4M/GD4D/GD4Y| GDBI4| GDHI4| GDSE4|GDRA4|GDCL4|GDTO4 |GDRC4 |GDSC4 |GDR4M/GDR4D/GDR4Y 5.GDC5| GDS5 | GDP5| GD5M/GD5D/GD5Y| GDBI5| GDHI5| GDSE5|GDRA5|GDCL5|GDTO5 |GDRC5 |GDSC5 |GDR5M/GDR5D/GDR5Y 6.GDC6| GDS6 | GDP6| GD6M/GD6D/GD6Y| GDBI6| GDHI6| GDSE6|GDRA6|GDCL6|GDTO6 |GDRC6 |GDSC6 |GDR6M/GDR6D/GDR6Y 7.GDC7| GDS7 | GDP7| GD7M/GD7D/GD7Y| GDBI7| GDHI7| GDSE7|GDRA7|GDCL7|GDTO7 |GDRC7 |GDSC7 |GDR7M/GDR7D/GDR7Y 8.GDC8| GDS8 | GDP8| GD8M/GD8D/GD8Y| GDBI8| GDHI8| GDSE8|GDRA8|GDCL8|GDTO8 |GDRC8 |GDSC8 |GDR8M/GDR8D/GDR8Y Underlying cause of dysfunction: outcome/current status code: 1. Uncertain 10. Viral hepatitis A 1. Resolved/controlled 2. Acute rejection 11. Viral hepatitis B 2. Unresolved/continuing/worsening 3. Chronic rejection 12. Viral hepatitis B&D 3. Retransplantation 4. Biliary strictures/obstruction/stones 13. Viral hepatitis C 4. Died (obstructive cholangiopathy) 14. Viral hepatitis E 5. Cannot determine 5. Alcohol abuse 15. Viral hepatitis unknown 6. Primary biliary cirrhosis 16. Steatosis 7. Primary sclerosing cholangitis 17. Primary non/dysfunction (within 1st 7 days posttx without HAT) 8. Autoimmune hepatitis 18. Liver biopsy complication, specify 9. Neoplasm, specify 19. Other, specify GRDFM (YN) _____ Check here if additional graft dysfunction, and document in COMMENTS section. Use the keywords MORE GRAFT to precede the comments. V. Any NEOPLASIA present during this evaluation period? Yes ___ No ___ NEOPL (YN) Use codes from opposite page for site, type, and treatment. neoplasms that occurred more than once, list each occurrence separately (one per line). PTLD/lymphoma(s), list each treatment separately (one per line). TREATMENT (PTLD/LYMPHOMA ONLY) Site |Type |If Other, specify | Cont. from| If new, Date|Primary/| Code |Start date | Stop date Code |Code | (30 char) | prev. eval| of Diagnosis|Metast. | |(MM/DD/YY) |(MM/DD/YY) (skin or | | | (check |(MM/DD/YY) |(circle | |(Enter -2 if |(Enter-2 if PTLD/lymphoma | | | if yes) | | | |began before |not ended) only) | | | | | | |eval. period)| ___(NEOPLS)____(NEOTYP)___________________________(YN)___________________(PRIMET)_(TRTMCO)_____________________ NS1 NT1 NO1 NP1 ND1M ND1D ND1Y NPM1 NTR1 NB1M NB1D NB1Y NE1M NE1D NE1Y 1. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ NS2 NT2 NO2 NP2 ND2M ND2D ND2Y NPM2 NTR2 NB2M NB2D NB2Y NE2M NE2D NE2Y 2. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ NS3 NT3 NO3 NP3 ND3M ND3D ND3Y NPM3 NTR3 NB3M NB3D NB3Y NE3M NE3D NE3Y 3. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ NS4 NT4 NO4 NP4 ND4M ND4D ND4Y NPM4 NTR4 NB4M NB4D NB4Y NE4M NE4D NE4Y 4. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 5. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 6. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 7. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 8. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 9. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 10. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 11. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 12. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 13. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 14. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ 15. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ NS16 NT16 NO16 NP16 ND16M ND16D ND16Y NPM16 NTR16 NB16M NB16D NB16Y NE16M NE16D NE16Y 16. _____ _____ ____________________________ _____ ___/___/___ P M _____ ___/___/___ ___/___/___ NEOPM (YN) ______Check here if additional neoplasms, and document in COMMENTS section. Use the keywords MORE NEO to precede the comments. VI. Any new RECURRENCE OF DISEASE since last evaluation? Yes ___ No ___ RDIS (YN) IF diagnosed during this evaluation period, check all that apply. (Refer to definitions on opposite page. For any given disease, ALL CRITERIA MUST BE MET.) Date of Onset (YN) (MM/DD/YY) RPBC __ 1. Primary biliary cirrhosis ___/___/___ RPBCM RPBCD RPBCY RPSC __ 2. Primary sclerosing cholangitis ___/___/___ RPSCM RPSCD RPSCY RAUH __ 3. Autoimmune hepatitis ___/___/___ RAUHM RAUHD RAUHY RNEOP __ 4. Neoplasm ___/___/___ RNEOM RNEOD RNEOY IF YES 4.1 Type ________________________________ RNEOT specify (30 char) 4.2 Site: 1. Intrahepatic__ RNEOI (YN) 2. Extrahepatic __ RNEOE (YN) (YN) RHEP __ 5. Hepatitis ___/___/___ RHEPM RHEPD RHEPY IF YES check type(s): (YN) RHEPA __ 5.1 Viral A RHEPB __ 5.2 Viral B RHEBD __ 5.3 Viral B & Delta RHEPC __ 5.4 Viral C RHEPU __ 5.5 Unknown (cryptogenic) RNASH __ 5.6 Non-alcoholic steato-hepatitis RHEPO __ 5.7 Other _________________________ RHEPS specify (30 char) (YN) RALD __ 6. Alcoholic liver disease (ALD) ___/___/___ RALDM RALDD RALDY RHEM __ 7. Hemochromatosis ___/___/___ RHEMM RHEMD RHEMY RLDO __ 8. Other, code liver disease diagnosis ______ RLDOC (LIVER) (see back of page) ________________________________RLDOS ___/___/___ RLDOM RLDOD RLDOY specify as required (30 char)