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PROTECT-CHILD Pediatric Transplant Data Implementation Guide
0.1.0-ci-build -

PROTECT-CHILD Pediatric Transplant Data Implementation Guide
0.1.0-ci-build - ci-build

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 BioSample logical model
.... 9.2 ClinicalEvent logical model
.... 9.3 ClinicalEventType logical model
.... 9.4 ClinicalVariable logical model
.... 9.5 ConcomitantMedication logical model
.... 9.6 Donor logical model
.... 9.7 ImmPat logical model
.... 9.8 Immunological Data logical model
.... 9.9 Immunosuppressant logical model
.... 9.10 InstrumentalInvestigation logical model
.... 9.11 LabResult logical model
.... 9.12 LabTest logical model
.... 9.13 Microbiology logical model
.... 9.14 Patient logical model
.... 9.15 PreMedication logical model
.... 9.16 Transplant logical model
.... 9.17 Visit logical model
.... 9.18 Vital Sign logical model
.... 9.19 Biological Sample
.... 9.20 Biological Sample Analysis Request
.... 9.21 Clinical Event
.... 9.22 Clinical Event Flag Observation
.... 9.23 Clinical Event Procedure
.... 9.24 Clinical Variable
.... 9.25 Concomitant Disease
.... 9.26 Concomitant Medication
.... 9.27 Donor liver graft type observation
.... 9.28 Immunological Data
.... 9.29 Immunosuppressant
.... 9.30 Immunosuppressant PK Observation
.... 9.31 Immunosuppressant to Patient
.... 9.32 Instrumental Investigation
.... 9.33 Intraoperative Complication
.... 9.34 Lab Result
.... 9.35 Lab Test
.... 9.36 Microbiology
.... 9.37 Microbiology Diagnosis
.... 9.38 Patient Demographics Observation
.... 9.39 Patient Instrumental Investigation
.... 9.40 Patient Pre-transplant Immunology Observation
.... 9.41 Patient Primary Disease Diagnosis
.... 9.42 Pre-transplant Medication
.... 9.43 Pre-transplant Medication — Child Record
.... 9.44 Study Centre
.... 9.45 Transplant
.... 9.46 Transplant Anastomosis
.... 9.47 Transplant Details
.... 9.48 Transplant Donor
.... 9.49 Transplant Recipient
.... 9.50 Visit
.... 9.51 Vital Sign
.... 9.52 Transplant donor reference
.... 9.53 Transplant type context
.... 9.54 Visit reference
.... 9.55 ABO Group ValueSet
.... 9.56 Banff Category ValueSet
.... 9.57 Biliary Anastomosis Type ValueSet
.... 9.58 Biological Sample Analysis Type ValueSet
.... 9.59 Clinical Event Flag ValueSet
.... 9.60 Clinical Event Procedure Type ValueSet
.... 9.61 Clinical Event Type ValueSet
.... 9.62 Concomitant Disease Category ValueSet
.... 9.63 Donor Liver Type ValueSet
.... 9.64 DSA HLA Class ValueSet
.... 9.65 Immunosuppressant Dose Unit ValueSet
.... 9.66 Immunosuppressant Drug Type
.... 9.67 Immunosuppressant Phase ValueSet
.... 9.68 Immunosuppressant PK Observation Type ValueSet
.... 9.69 Instrumental Investigation Name
.... 9.70 Intraoperative Complications ValueSet
.... 9.71 Lab Result Unit ValueSet
.... 9.72 Lab Test Name ValueSet
.... 9.73 MFI Category ValueSet
.... 9.74 Microbiology Diagnosis ValueSet
.... 9.75 Patient Instrumental Investigation Result ValueSet
.... 9.76 Pre-medication Antihypertensive Drug ValueSet
.... 9.77 Rh Factor ValueSet
.... 9.78 Transplant Anastomosis Type ValueSet
.... 9.79 Transplant Type ValueSet
.... 9.80 Ureteral Anastomosis Type ValueSet
.... 9.81 Vascular Complication Type ValueSet
.... 9.82 Visit Type ValueSet
.... 9.83 ABO Group CodeSystem
.... 9.84 Banff Category CodeSystem
.... 9.85 Biological Sample Analysis Type
.... 9.86 Clinical Event Evidence CodeSystem
.... 9.87 Clinical Event Procedure Type CodeSystem
.... 9.88 Clinical Event Type CodeSystem
.... 9.89 Concomitant Disease Category CodeSystem
.... 9.90 Donor Liver Type CodeSystem
.... 9.91 DSA HLA Class CodeSystem
.... 9.92 Immunological Data Component Codes
.... 9.93 Immunological Data Panel CodeSystem
.... 9.94 Immunosuppressant Drug Type
.... 9.95 Immunosuppressant Phase CodeSystem
.... 9.96 Immunosuppressant PK Observation Type CodeSystem
.... 9.97 Instrumental Investigation Name
.... 9.98 Intraoperative Complications CodeSystem
.... 9.99 Lab Test Local Codes
.... 9.100 MFI Category CodeSystem
.... 9.101 Microbiology component codes
.... 9.102 Patient Instrumental Investigation Component Codes
.... 9.103 Patient Instrumental Investigation Result CodeSystem
.... 9.104 Patient Observations Panel CodeSystem
.... 9.105 PRA Type CodeSystem
.... 9.106 Pre-medication Antihypertensive Drug CodeSystem
.... 9.107 Rh Factor CodeSystem
.... 9.108 Transplant Detail CodeSystem
.... 9.109 Transplant Type CodeSystem
.... 9.110 Type of surgical biliary anastomosis CodeSystem
.... 9.111 Ureteral Graft Anastomosis Type CodeSystem
.... 9.112 Vascular Complication Type CodeSystem
.... 9.113 Visit Type CodeSystem
.... 9.114 Vital Sign Local Codes
.... 9.115 PROTECT-CHILD identifier namespace
.... 9.116 Study centre identifier namespace
.... 9.117 Example 12-month follow-up visit
.... 9.118 Example 6-month follow-up visit
.... 9.119 Example Biological Sample
.... 9.120 Example Clinical Event Flag — Treatment adherence confirmed
.... 9.121 Example Clinical Event Procedure — Hemodialysis
.... 9.122 Example Clinical Event Procedure — Retransplantation
.... 9.123 Example Clinical Event Procedure — Transplant List Entry
.... 9.124 Example Clinical Event — acute kidney injury after liver transplant
.... 9.125 Example Clinical Event — Liver Rejection START
.... 9.126 Example Clinical Variable
.... 9.127 Example clinical-event visit
.... 9.128 Example Concomitant Disease
.... 9.129 Example Concomitant Medication
.... 9.130 Example donor age observation
.... 9.131 Example donor liver graft type
.... 9.132 Example genomic analysis request
.... 9.133 Example ImmPat PK Observation — Pre-dose level
.... 9.134 Example ImmPat — maintenance reduced after EBV reactivation
.... 9.135 Example ImmPat — steroid pulse for the rejection episode
.... 9.136 Example Immunological Data — biopsy work-up at the rejection episode
.... 9.137 Example Immunological Data — pre-transplant typing
.... 9.138 Example Immunosuppressant
.... 9.139 Example Immunosuppressant to Patient — Induction
.... 9.140 Example Immunosuppressant to Patient — Maintenance
.... 9.141 Example Immunosuppressant — Basiliximab
.... 9.142 Example Immunosuppressant — Tacrolimus
.... 9.143 Example Instrumental Investigation
.... 9.144 Example Intraoperative Complication
.... 9.145 Example Lab Result Observation
.... 9.146 Example Lab Result Observation — 12-month visit
.... 9.147 Example Lab Result — Alanine aminotransferase at the rejection episode
.... 9.148 Example Lab Result — Alanine aminotransferase, 1-month visit
.... 9.149 Example Lab Result — Alanine aminotransferase, 12-month visit
.... 9.150 Example Lab Result — Albumin, 1-month visit
.... 9.151 Example Lab Result — Albumin, 12-month visit
.... 9.152 Example Lab Result — Gamma glutamyl transferase at the rejection episode
.... 9.153 Example Lab Result — Total bilirubin at the rejection episode
.... 9.154 Example Lab Test
.... 9.155 Example Microbiology Diagnosis
.... 9.156 Example Microbiology record
.... 9.157 Example patient age observation
.... 9.158 Example Patient Instrumental Investigation
.... 9.159 Example Patient Instrumental Investigation — liver biopsy at the 1-month visit
.... 9.160 Example patient liver disease diagnosis
.... 9.161 Example patient pre-transplant immunology observation
.... 9.162 Example patient renal disease diagnosis
.... 9.163 Example Pre-medication
.... 9.164 Example Pre-medication — Rituximab desensitisation (child record)
.... 9.165 Example pre-transplant visit and transplant admission
.... 9.166 Example transplant
.... 9.167 Example Transplant Anastomosis
.... 9.168 Example Transplant Details
.... 9.169 Example transplant donor
.... 9.170 Example transplant recipient
.... 9.171 Example visit
.... 9.172 Example Vital Sign
.... 9.173 Example Vital Sign — 12-month visit
.... 9.174 Kidney example — 1-month follow-up visit
.... 9.175 Kidney example — acute kidney rejection episode
.... 9.176 Kidney example — antibody induction
.... 9.177 Kidney example — biopsy immunology panel
.... 9.178 Kidney example — BK virus infection
.... 9.179 Kidney example — BK virus nephropathy
.... 9.180 Kidney example — BK virus surveillance panel
.... 9.181 Kidney example — clinical-event visit for BK-virus nephropathy
.... 9.182 Kidney example — clinical-event visit for the rejection episode
.... 9.183 Kidney example — creatinine at graft failure
.... 9.184 Kidney example — creatinine at the 1-month visit
.... 9.185 Kidney example — creatinine at the rejection episode
.... 9.186 Kidney example — creatinine at the rejection episode
.... 9.187 Kidney example — delayed kidney graft function
.... 9.188 Kidney example — graft Doppler ultrasound
.... 9.189 Kidney example — graft failure
.... 9.190 Kidney example — haemodialysis for delayed graft function
.... 9.191 Kidney example — intra-operative complication
.... 9.192 Kidney example — living related donor DON-2-0001
.... 9.193 Kidney example — maintenance immunosuppression
.... 9.194 Kidney example — pre-transplant visit and transplant admission
.... 9.195 Kidney example — primary renal disease
.... 9.196 Kidney example — recipient age at transplant
.... 9.197 Kidney example — recipient REC-2-0001
.... 9.198 Kidney example — relisted for retransplantation
.... 9.199 Kidney example — return to haemodialysis
.... 9.200 Kidney example — steroid pulse for the rejection episode
.... 9.201 Kidney example — tacrolimus reduced for BK-virus nephropathy
.... 9.202 Kidney example — tacrolimus trough level
.... 9.203 Kidney example — termination visit
.... 9.204 Kidney example — the transplant
.... 9.205 Kidney example — ureteral anastomosis
.... 9.206 Kidney example — vital signs at the 1-month visit
.... 9.207 PROTECT-CHILD Centre 1 — La Paz
.... 9.208 PROTECT-CHILD Centre 2 — Padova
.... 9.209 PROTECT-CHILD Centre 3 — Palma
.... 9.210 PROTECT-CHILD Centre 4 — Hamburg
.... 9.211 Worked Example (kidney) — recipient REC-2-0001
.... 9.212 Worked Example — recipient REC-1-0001 full transplant journey