PROTECT-CHILD Pediatric Transplant Data Implementation Guide, published by Protect Child. This guide is not an authorized publication; it is the continuous build for version 0.1.0-ci-build built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/protect-child/ and changes regularly. See the Directory of published versions

Table of Contents

0 Table of Contents

1 Home

2 Logical Models

3 Data Model (ERD)

4 Data Dictionary

5 Model Maps

5.1 Patient

5.2 Donor

5.3 Visit

5.4 Transplant

5.5 Immunological Data

5.6 Vital Sign

5.7 BioSample

5.8 Pre-Medication

5.9 Clinical Variable

5.10 Concomitant Medication

5.11 Microbiology

5.12 Instrumental Investigation

5.13 Immunosuppressant

5.14 Laboratory

5.15 Clinical Event Type

5.16 Clinical Event

6 DM → FHIR → OMOP Crosswalk

7 Worked Example — Liver

8 Worked Example — Kidney

9 Artifacts Summary

9.1 Kidney transplant data source

9.2 Liver transplant data source

9.3 BioSample logical model

9.4 ClinicalEvent logical model

9.5 ClinicalEventType logical model

9.6 ClinicalVariable logical model

9.7 ConcomitantMedication logical model

9.8 Donor logical model

9.9 ImmPat logical model

9.10 Immunological Data logical model

9.11 Immunosuppressant logical model

9.12 InstrumentalInvestigation logical model

9.13 LabResult logical model

9.14 LabTest logical model

9.15 Microbiology logical model

9.16 Patient logical model

9.17 PreMedication logical model

9.18 Transplant logical model

9.19 Visit logical model

9.20 Vital Sign logical model

9.21 ANCA Observation

9.22 Anti-HLA Antibody

9.23 Anti-HLA Antibody Screen

9.24 Banff Assessment

9.25 Biological Sample

9.26 Biological Sample Analysis Request

9.27 Blood Group Observation

9.28 C4d Stain

9.29 Clinical Event

9.30 Clinical Event Flag Observation

9.31 Clinical Event Procedure

9.32 Clinical Variable

9.33 Concomitant Disease

9.34 Concomitant Medication

9.35 Concomitant Procedure

9.36 Donor liver graft type observation

9.37 Donor Type Observation

9.38 Graft Biopsy

9.39 Graft Episode

9.40 HLA Typing

9.41 Immunological Data Report

9.42 Immunosuppressant

9.43 Immunosuppressant PK Observation

9.44 Immunosuppressant to Patient

9.45 Instrumental Investigation

9.46 Intraoperative Complication

9.47 Lab Result

9.48 Lab Result (qualitative)

9.49 Lab Result (quantitative)

9.50 Lab Test

9.51 Liver Rejection Activity Index

9.52 Microbiology Culture

9.53 Microbiology Diagnosis

9.54 Microbiology Nucleic Acid Detection

9.55 Microbiology Report

9.56 Microbiology Result

9.57 Microbiology Serology

9.58 Microbiology Viral Load

9.59 Patient Demographics Observation

9.60 Patient Instrumental Investigation

9.61 Patient Pre-transplant Immunology Observation

9.62 Patient Primary Disease Diagnosis

9.63 Pre-transplant Medication

9.64 Pre-transplant Medication — Rituximab or Antiviral Prophylaxis

9.65 Study Centre

9.66 Transplant

9.67 Transplant Admission

9.68 Transplant Anastomosis

9.69 Transplant Details

9.70 Transplant Donor

9.71 Transplant Recipient

9.72 Visit

9.73 Vital Sign

9.74 Clinical event end visit

9.75 IMGT/HLA database version

9.76 Transplant donor reference

9.77 Transplant type context

9.78 Visit reference

9.79 ABO Group ValueSet

9.80 ANCA Test ValueSet

9.81 Anti-HLA Antibody Identity ValueSet

9.82 Anti-HLA Antibody Screen ValueSet

9.83 Banff C4d Score ValueSet

9.84 Banff Category ValueSet

9.85 Banff Lesion Score ValueSet

9.86 Biliary Anastomosis Type ValueSet

9.87 Biological Sample Analysis Type ValueSet

9.88 Blood Group Result ValueSet

9.89 Blood Group Test ValueSet

9.90 Clinical Event Flag ValueSet

9.91 Clinical Event Procedure Status

9.92 Clinical Event Procedure Type ValueSet

9.93 Clinical Event Type ValueSet

9.94 Concomitant Disease Category ValueSet

9.95 Concomitant Medication ValueSet

9.96 Concomitant Procedure ValueSet

9.97 Detection Result

9.98 Donor Liver Type ValueSet

9.99 Donor Type

9.100 DSA HLA Class ValueSet

9.101 HLA Typing ValueSet

9.102 Immunosuppressant Dose Form

9.103 Immunosuppressant Dose Unit ValueSet

9.104 Immunosuppressant Drug Type ValueSet

9.105 Immunosuppressant Phase ValueSet

9.106 Immunosuppressant PK Measurement ValueSet

9.107 Immunosuppressant PK Observation Type ValueSet

9.108 Instrumental Investigation Name ValueSet

9.109 Intraoperative Complications ValueSet

9.110 Lab Result Unit ValueSet

9.111 Lab Test Name ValueSet

9.112 Liver RAI Component ValueSet

9.113 MFI Category ValueSet

9.114 Microbiology Culture Tests

9.115 Microbiology Diagnosis ValueSet

9.116 Microbiology Nucleic Acid Detection Tests

9.117 Microbiology Serology Tests

9.118 Microbiology Tests (all)

9.119 Microbiology Viral Load Tests

9.120 Patient Instrumental Investigation Result ValueSet

9.121 Pre-medication Antihypertensive Drug ValueSet

9.122 PROTECT-CHILD DM immunological_data variables

9.123 PROTECT-CHILD DM microbiology variables

9.124 Qualitative Lab Result ValueSet

9.125 Rh Factor ValueSet

9.126 Serology Result

9.127 Transplant Anastomosis Type ValueSet

9.128 Transplant Type ValueSet

9.129 Ureteral Anastomosis Type ValueSet

9.130 Vascular Complication Type ValueSet

9.131 Viral Load Unit

9.132 Visit Type ValueSet

9.133 ABO Group CodeSystem

9.134 Banff C4d Score CodeSystem

9.135 Banff Category CodeSystem

9.136 Biological Sample Analysis Type

9.137 Clinical Event Evidence CodeSystem

9.138 Clinical Event Procedure Type CodeSystem

9.139 Clinical Event Type CodeSystem

9.140 Concomitant Disease Category CodeSystem

9.141 Donor Liver Type CodeSystem

9.142 DSA HLA Class CodeSystem

9.143 Graft Pathology Codes

9.144 Immunological Data Component Codes

9.145 Immunological Data Panel CodeSystem

9.146 Immunosuppressant Drug Type CodeSystem

9.147 Immunosuppressant Phase CodeSystem

9.148 Immunosuppressant PK Observation Type CodeSystem

9.149 Instrumental Investigation Name CodeSystem

9.150 Intraoperative Complications CodeSystem

9.151 Lab Test Local Codes

9.152 MFI Category CodeSystem

9.153 Patient Instrumental Investigation Component Codes

9.154 Patient Instrumental Investigation Result CodeSystem

9.155 Patient Observations Panel CodeSystem

9.156 PRA Type CodeSystem

9.157 Pre-medication Antihypertensive Drug CodeSystem

9.158 PROTECT-CHILD Data Model Variables

9.159 PROTECT-CHILD Microbiology Local Codes

9.160 PROTECT-CHILD OMOP custom concepts

9.161 Rh Factor CodeSystem

9.162 Transplant Detail CodeSystem

9.163 Transplant Type CodeSystem

9.164 Type of surgical biliary anastomosis CodeSystem

9.165 Ureteral Graft Anastomosis Type CodeSystem

9.166 Vascular Complication Type CodeSystem

9.167 Visit Type CodeSystem

9.168 Vital Sign Local Codes

9.169 PROTECT-CHILD identifier namespace

9.170 Study centre identifier namespace

9.171 BiliaryAnastomosisTypeCS → standard codes

9.172 BioSample logical model → FHIR

9.173 ClinicalEvent logical model → FHIR

9.174 ClinicalEventProcedureTypeCS → standard codes

9.175 ClinicalEventType logical model → FHIR

9.176 ClinicalEventTypeCS → standard codes

9.177 ClinicalVariable logical model → FHIR

9.178 ConcomitantDiseaseCategory → standard codes

9.179 ConcomitantMedication logical model → FHIR

9.180 DM bio_sample → OMOP

9.181 DM boolean → detection result

9.182 DM boolean → serology result

9.183 DM clinical_event → OMOP

9.184 DM clinical_event_type → OMOP

9.185 DM clinical_variable → OMOP

9.186 DM concomitant_medication → OMOP

9.187 DM donor → OMOP

9.188 DM immunological_data columns → FHIR codes

9.189 DM immunological_data → OMOP

9.190 DM immunosuppressant → OMOP

9.191 DM imm_pat → OMOP

9.192 DM instrumental_investigation → OMOP

9.193 DM lab_result → OMOP

9.194 DM lab_test → OMOP

9.195 DM microbiology columns → FHIR test codes

9.196 DM microbiology → OMOP

9.197 DM patient → OMOP

9.198 DM pre_medication → OMOP

9.199 DM transplant → OMOP

9.200 DM visit → OMOP

9.201 DM vital_sign → OMOP

9.202 Donor logical model → FHIR

9.203 DonorLiverTypeCS → standard codes

9.204 ImmPat logical model → FHIR

9.205 Immunological Data logical model → FHIR

9.206 Immunosuppressant logical model → FHIR

9.207 ImmunosuppressantDrugTypeCS → standard codes

9.208 InstrumentalInvestigation logical model → FHIR

9.209 InstrumentalInvestigationNameCS → standard codes

9.210 IntraoperativeComplicationCS → standard codes

9.211 LabResult logical model → FHIR

9.212 LabTest logical model → FHIR

9.213 Microbiology logical model → FHIR

9.214 MicrobiologyCS → standard codes

9.215 Patient logical model → FHIR

9.216 PreMedication logical model → FHIR

9.217 PreMedicationAntihypertensiveDrugCS → standard codes

9.218 Transplant logical model → FHIR

9.219 TransplantTypeCS → standard codes

9.220 UreteralAnastomosisTypeCS → standard codes

9.221 VascularComplicationTypeCS → standard codes

9.222 Visit logical model → FHIR

9.223 Vital Sign logical model → FHIR

9.224 BK virus DNA in blood — not detected

9.225 BK virus DNA in urine — not detected

9.226 CMV DNA — not detected

9.227 CMV IgG — positive

9.228 CMV IgM — negative

9.229 Donor CMV IgG — positive

9.230 Donor CMV IgM — negative

9.231 Donor EBNA IgG — positive

9.232 Donor EBV VCA IgG — positive

9.233 EBNA IgG — positive

9.234 EBV early antigen IgM — negative

9.235 EBV VCA IgG — positive

9.236 EBV VCA IgM — negative

9.237 EBV viral load — 2,450 copies/mL

9.238 Example 12-month follow-up visit

9.239 Example 6-month follow-up visit

9.240 Example Biological Sample

9.241 Example Clinical Event Flag — treatment adherence

9.242 Example Clinical Event Procedure — Hemodialysis

9.243 Example Clinical Event — acute kidney injury after liver transplant

9.244 Example Clinical Event — liver rejection episode

9.245 Example Clinical Variable

9.246 Example clinical-event visit

9.247 Example Concomitant Disease

9.248 Example Concomitant Medication

9.249 Example Concomitant Procedure — ERCP

9.250 Example donor age observation

9.251 Example donor liver graft type

9.252 Example donor type — deceased

9.253 Example genomic analysis request

9.254 Example graft biopsy — liver, rejection episode

9.255 Example graft episode — the liver graft

9.256 Example ImmPat PK Observation — Pre-dose level

9.257 Example ImmPat — maintenance reduced after EBV reactivation

9.258 Example ImmPat — steroid pulse for the rejection episode

9.259 Example immunological data report — antibodies at the rejection episode

9.260 Example immunological data report — donor typing

9.261 Example immunological data report — pre-transplant typing

9.262 Example Immunosuppressant

9.263 Example Immunosuppressant to Patient — Induction

9.264 Example Immunosuppressant to Patient — Maintenance

9.265 Example Immunosuppressant — Tacrolimus

9.266 Example Instrumental Investigation

9.267 Example Intraoperative Complication

9.268 Example Lab Result Observation

9.269 Example Lab Result Observation — 12-month visit

9.270 Example Lab Result — Alanine aminotransferase at the rejection episode

9.271 Example Lab Result — Alanine aminotransferase, 1-month visit

9.272 Example Lab Result — Alanine aminotransferase, 12-month visit

9.273 Example Lab Result — Albumin, 1-month visit

9.274 Example Lab Result — Albumin, 12-month visit

9.275 Example Lab Result — Gamma glutamyl transferase at the rejection episode

9.276 Example Lab Result — Total bilirubin at the rejection episode

9.277 Example Lab Test

9.278 Example Lab Test — creatinine, with paediatric reference intervals

9.279 Example Microbiology Diagnosis

9.280 Example Microbiology Report — donor serology

9.281 Example Microbiology Report — liver recipient, 1-month visit

9.282 Example Patient Instrumental Investigation

9.283 Example Patient Instrumental Investigation — liver biopsy at the 1-month visit

9.284 Example patient liver disease diagnosis

9.285 Example patient pre-transplant immunology observation

9.286 Example Pre-medication

9.287 Example Pre-medication — Rituximab desensitisation

9.288 Example pre-transplant visit

9.289 Example transplant

9.290 Example transplant admission

9.291 Example Transplant Anastomosis

9.292 Example Transplant Details

9.293 Example transplant donor

9.294 Example transplant recipient

9.295 Example visit

9.296 Example Vital Sign

9.297 Example Vital Sign — 12-month visit

9.298 Example — ANCA at the rejection episode

9.299 Example — anti-smooth muscle antibody at the rejection episode

9.300 Example — antinuclear antibody at the rejection episode

9.301 Example — C4d stain, liver graft

9.302 Example — creatinine reported in µmol/L

9.303 Example — de novo donor-specific antibody against B*08:01

9.304 Example — donor A*01:01

9.305 Example — donor A*02:01

9.306 Example — donor ABO group

9.307 Example — donor B*08:01

9.308 Example — donor B*44:03

9.309 Example — donor C*07:01

9.310 Example — donor C*16:01

9.311 Example — donor DQB1*02:01

9.312 Example — donor DQB1*02:02

9.313 Example — donor DRB1*03:01

9.314 Example — donor DRB1*07:01

9.315 Example — donor Rh factor

9.316 Example — estimated GFR by the Schwartz formula

9.317 Example — liver Banff Rejection Activity Index

9.318 Example — liver graft biopsy specimen

9.319 Example — pre-transplant anti-HLA antibody screen

9.320 Example — recipient A*02:01

9.321 Example — recipient A*24:02

9.322 Example — recipient ABO group

9.323 Example — recipient B*07:02

9.324 Example — recipient B*44:03

9.325 Example — recipient C*07:02

9.326 Example — recipient C*16:01

9.327 Example — recipient DPB1*02:01

9.328 Example — recipient DPB1*04:01

9.329 Example — recipient DQB1*02:01

9.330 Example — recipient DQB1*06:02

9.331 Example — recipient DRB1*03:01

9.332 Example — recipient DRB1*15:01

9.333 Example — recipient Rh factor

9.334 Kidney example — 1-month follow-up visit

9.335 Kidney example — abdominal ultrasound

9.336 Kidney example — ABPM 24-hour means at the PRES visit

9.337 Kidney example — albumin, month 1

9.338 Kidney example — ALT, month 1

9.339 Kidney example — ambulatory blood pressure monitoring

9.340 Kidney example — arterial hypertension

9.341 Kidney example — AST, month 1

9.342 Kidney example — brain MRI

9.343 Kidney example — calcium, month 1

9.344 Kidney example — cholesterol, month 1

9.345 Kidney example — clinical variables at the pre-transplant visit

9.346 Kidney example — clinical-event visit for PRES

9.347 Kidney example — creatinine, month 1

9.348 Kidney example — cystatin C, month 1

9.349 Kidney example — donor A*24

9.350 Kidney example — donor A*30

9.351 Kidney example — donor ABO group

9.352 Kidney example — donor age at donation

9.353 Kidney example — donor B*07

9.354 Kidney example — donor B*14

9.355 Kidney example — donor CMV IgG, positive

9.356 Kidney example — donor CMV IgM, negative

9.357 Kidney example — donor DRB1*04

9.358 Kidney example — donor DRB1*15

9.359 Kidney example — donor EBNA IgG, positive

9.360 Kidney example — donor EBV early antigen IgM, negative

9.361 Kidney example — donor EBV VCA IgG, positive

9.362 Kidney example — donor EBV VCA IgM, negative

9.363 Kidney example — donor Rh factor

9.364 Kidney example — donor serology

9.365 Kidney example — donor type (living)

9.366 Kidney example — donor typing

9.367 Kidney example — echocardiogram

9.368 Kidney example — eGFR (creatinine), month 1

9.369 Kidney example — eGFR (cystatin C), month 1

9.370 Kidney example — erythrocytes, month 1

9.371 Kidney example — GGT, month 1

9.372 Kidney example — glucose, month 1

9.373 Kidney example — haematocrit, month 1

9.374 Kidney example — haemoglobin, month 1

9.375 Kidney example — LDH, month 1

9.376 Kidney example — leukocytes, month 1

9.377 Kidney example — living donor DON-2-0001

9.378 Kidney example — maintenance methylprednisolone

9.379 Kidney example — maintenance tacrolimus

9.380 Kidney example — phosphate, month 1

9.381 Kidney example — platelets, month 1

9.382 Kidney example — posterior reversible encephalopathy syndrome

9.383 Kidney example — potassium, month 1

9.384 Kidney example — pre-transplant visit

9.385 Kidney example — primary renal disease

9.386 Kidney example — recipient ABO group

9.387 Kidney example — recipient blood group

9.388 Kidney example — recipient REC-2-0001

9.389 Kidney example — recipient Rh factor

9.390 Kidney example — sodium, month 1

9.391 Kidney example — the kidney graft

9.392 Kidney example — the transplant

9.393 Kidney example — total bilirubin, month 1

9.394 Kidney example — transplant admission

9.395 Kidney example — transplant details

9.396 Kidney example — urea, month 1

9.397 Kidney example — uric acid, month 1

9.398 Kidney example — urine protein/creatinine ratio at the PRES visit

9.399 Kidney example — vital signs at the pre-transplant visit

9.400 PROTECT-CHILD Centre 1 — La Paz

9.401 PROTECT-CHILD Centre 2 — Padova

9.402 PROTECT-CHILD Centre 3 — Palermo

9.403 PROTECT-CHILD Centre 4 — Hamburg

9.404 Worked Example (kidney) — recipient REC-2-0001

9.405 Worked Example — recipient REC-1-0001 full transplant journey