Draft Version 1.110

 

Previous versions

Version 1.90

  • tblART
    • added new optional field GENERIC
    • added new optional field ART_RS2
    • added new optional field ART_RS3
    • added new optional field ART_RS4
    • ART_ID
      • Added new single tablet formulations:
        • J05AR15 (Atazanavir and cobicistat)
        • J05AR16 (Lamivudine and raltegravir)
        • J05AR17 (Emtricitabine and tenofovir alafenamide)
        • J05AR18 (Emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat)
        • J05AR19 (Emtricitabine, tenofovir alafenamide and rilpivirine)
      • Deleted (moved to tblMED):
        • J05AF08";"Adefovir (PREVEON)"
        • J05AF10";"Entecavir"
        • J05AF11";"Telbivudine"
    • ART_RS
      • added new (sub-)codes for stopping medication
        • 11 (Bone toxicity)
        • 15 (Social contra-indication)
        • 16 (Contra-indication unspecified)
        • 16.8 (Contra-indication expired)
        • 16.9 (Contra-indication - other)
        • 17 (MTCT regimen completed)
        • 70 (Pregnancy - toxicity concerns (during pregnancy))
        • 75 (Pregnancy - switch to a more appropriate regimen for PMTCT)
        • 92.5 (Regular treatment termination (e.g. DAA's for HCV, antibiotics)
  • tblBAS
    • Added field for Center CENTER
  • tblCENTER
    • Added table
  • tblLAB
    • LAB_U
      • Deleted 18 (µkat/L, was same as 11)
  • tblLTFU
    • DEATH_R1
      • added new subcodes:
        • 03.1.3 (HCV with liver cancer)
        • 03.2.3 (HBV with liver cancer)
  • tblMED
    • MED_ID
      • Added new drug codes:
        • A11CC (vitamin D)
        • G02CA (Tocolysis)
        • H02 (Corticosteroids)
        • J01 (Antibiotics)
        • J01GA01 (streptomycin)
        • J02AC05 (Isavuconazole)
        • J02AX04 (caspofungin)
        • J04AB05 (Rifapentine (Priftin))
        • J05AF12 (Clevudine)
        • J05AX GRAZ-ELB (Grazoprevir/Elbasvir)
        • J05AR-DAAS (Daclatasvir/Asunaprevir)
        • J07BM0 (HPV Vaccine)
        • J07BM01 (HPV Vaccine (types 6, 11, 16, 18))
        • J07BM02 (HPV Vaccine (types 16, 18))
        • J07BM03 (HPV Vaccine (types 6, 11, 16, 18, 31, 33, 45, 52, 58))
        • M05BA (bisphosphonate)
        • N05A (Antipsychotics)
        • N05CD (Benzodiazepine derivatives)
        • N05CF (Benzodiazepine related drugs)
        • N06A (Antidepressant)
        • N07BC (Other drugs used in opioid dependence)
        • N07BC01 (Buprenorphine)
        • N07BC02 (Methadone)
        • N07BC03 (Levacetylmethadol)
        • N07BC04 (Lofexidine)
        • N07BC51 (Buprenorphine, combinations)
        • V03AB15 (Naloxone)
      • Added new drug codes (moved from tblART):
        • J05AF08";"Adefovir (PREVEON)"
        • J05AF10";"Entecavir"
        • J05AF11";"Telbivudine"
      • Changed temporary drug names to ATC codes:
        • J05AR-A450OM (ABT-450/r/Ombitasvir) --> J05AX67 (Ombitasvir, paritaprevir(ABT-450) and ritonavir)
        • J05AR-LESO (Ledipasvir/Sofosbuvir) --> J05AX65 (Ledipasvir/Sofosbuvir)
        • J05AX-DBV (Dasabuvir) --> J05AX16 (Dasabuvir)
    • MED_RS
      • added new (sub-)codes for stopping medication (to keep identical to ART_RS)
        • 11 (Bone toxicity)
        • 15 (Social contra-indication)
        • 16 (Contra-indication unspecified)
        • 16.8 (Contra-indication expired)
        • 16.9 (Contra-indication - other)
        • 17 (MTCT regimen completed)
        • 70 (Pregnancy - toxicity concerns (during pregnancy))
        • 75 (Pregnancy - switch to a more appropriate regimen for PMTCT)
        • 92.5 (Regular treatment termination (e.g. DAA's for HCV, antibiotics)
  • tblPROGRAM
    • Added table
  • tblVIS
    • Added field for Center CENTER
    • Added field for family history of CVD/Stroke FAM_Y
    • Added field for type of clinic/service CLIN_TYPE
    • Added field for speciality of physician SPEC_TYPE
    • Added field for stage of transition from adolescence to adulthood TRANS_STAGE

Version 1.80

  • tblART
    • ART_ID
      • Added:
        • J05AR11 (Lamivudine, tenofovir disoproxil and efavirenz)
        • J05AR12 (Lamivudine and tenofovir disoproxil)
        • J05AR13 (Lamivudine, abacavir and dolutegravir)
        • J05AR14 (Darunavir and cobicistat)
        • J05AX-CAB (Cabotegravir (GSK-744))
  • tblBAS
    • ETHNIC
      • Revised and added codes for different ethnicities
      • Changed limitations
      • Changed description
    • ORIGIN
      • Changed description to be more specific
  • tblCANC
    • Added table
  • tblLTFU
    • DEATH_R1
      • Added sub-types for 22 and 23
      • Added additional codes table
  • tblMED
    • MED_ID
      • Added:
        • J05AE11 (Telaprevir (INCIVEK, INCIVO))
        • J05AE13 (Faldaprevir)
        • J05AE14 (Simeprevir)
        • J05AE15 (Asunaprevir)
        • J05AX14 (Daclatasvir)
        • J05AX15 (Sofosbuvir)
        • J05AR-A450OM (ABT-450/r/Ombitasvir)
        • J05AR-DAAS (Daclatasvir/Asunaprevir)
        • J05AR-LESO (Ledipasvir/Sofosbuvir)
        • J05AX-DBV (Dasabuvir)
  • tblLAB
    • LAB_U
      • Added:
        • 14 (mg/24h)
        • 15 (mg/mmol)
        • 16 (fl)
        • 17 (µg/mL = mg/L)
        • 18 (µkat/L)
    • LAB_ID
      • Added:
        • ACRA (Albumin Creatinin Ratio)
        • PCRA (Protein Creatinin Ratio)
        • PROT (Protein)
        • PSA (Prostate-specific antigen)
        • PTH (Parathyroid Hormone)

Version 1.70

  • tblAE has been renamed to tblCEP
  • tblCEP
    • Added field CEP_V
    • CEP_ID
      • Added: HOSP, ICU, JAUN, LIVD, LIVT, USAB, ASP, BART, CHAG, NOCA, PCE, PMAR, REQU.
      • Added: BACT, ENDO, MENI, OSTI, PERI, PNEU, PYEL, LEIS, MCDI (Previously in tblDIS).
      • Removed: ANG, BYP, END as they are already in the field CEP_SPEC.
      • Removed COR as now specified with SUD_DEATH_Y and EXP_DEATH_Y in tblLTFU.
    • CEP_SPEC
      • Changed description of NADM - CERV to contain "grade 2 or higher"
      • Added values: LIVB - XX, HEP - XX, NADM - HENE, NADM - BRAIN
  • tblBAS
    • Added field RECART_D (Date ART started)
    • Added field LTART_D (Date last assessed for ART)
    • ETHNIC: Added Limitations section in description
    • Added field EDU_LVL (Last completed education Level)
    • Added field HIV_POS_D (Date of first positive HIV test)
  • tblDIS
    • DIS_ID: Removed HG, BACT, ENDO, MENI, OSTI, PERI, PNEU, PYEL, LEIS, MCDI (now in tblCEP).
  • tblVIS
    • Added optional field EMPLOY (What is the patient's current situation regarding labour?)
    • Added optional field CONTRACT (If the patient is an employee, what is the type of the patient's employment contract?)
    • Added optional field SMOKING_Y (Is the patient currently a smoker?)
    • Added optional field PREG_Y (Is the patient currently pregnant?)
    • Added optional field CDC_STAGE
    • Added optional field WHO_STAGE
  • tblLTFU
    • Added optional fields for ICD9 cause of death coding (ICD9_#)
    • Added optional field DEATH_SOURCE
    • Added optional fields SUD_DEATH_Y and EXP_DEATH_Y. Replacing COR
    • CoDe
      • Typos in the coding table (HBF -> HBV)
      • New codes for cancer (04.XX)
      • New codes for AMI (08.XX)
      • New code: 92.1 - Unknown, competing risks
  • tblART
    • ART_ID: Coding extended/updated to match current ATC codes.
      • Lopinavir / Ritonavir changed code from "J05AE06" to "J05AR10".
      • Elvitegravir changed code from "J05AX-EVG" to "J05AX11"
      • J05AR07 - Triomune
      • J05AR08 - Eviplera / Complera
      • J05AR09 - Stribild
      • J05AR10 - Kaletra / Aluvia
      • J05AX12 - Dolutegravir
      • V03AX03 - Cobicistat
    • ART_FR: Added 0.33 and 0.5. Added special value -1 for "frequency unknown".
    • ART_RS
      • Added new codes: 6.X, 92.31, 92.32, 92.33, 92.4, 92.9, 94.2, 96.1, 96.2, 97.1, 97.2, 97.6
  • tblLAB
    • LAB_ID
      • Removed redundant "APT" code. Use code "ALP"
      • Removed "GLYCE" (synonymous to Glucose in blood)
      • Added "AFP" (Alfa Fetoprotein) and "DIPP" (Dipstick result for protein in Urine).
    • LAB_U
      • Removed WBC codes (WBC was already removed from LAB_ID)
      • Added generic "13 - µg/L" and "99 - No units" code
    • LAB_ST
      • Added codes U and U24.
  • tblLAB_RES
    • SUBTYPEModified description to also include HCV
  • tblLAB_RNA
    • RNA_T
      • New code: 42 - Abbott RealTime HIV-1 m2000
      • New code: 59 - Monitor unspecified
  • tblMED
    • MED_ID
      • Changed description from "Other HIV-related drugs" to "Other medication"
      • Added codes for Boceprevir and Telaprevir
    • MED_RS
      • Same changes as in tblART ART_RS
  • tblLAB_VIRO
    • VS_TNew codes 6,7,8.

Version 1.60

  • tblBAS:
    • The ORIGIN field is now coded using UN region and country codes.
    • Added optional SEROHOW field indicating how the seroconversion date was determined.
    • Added optional CENS_D field holding the last date the database was updated for a patient.
  • tblREFILLcreated to hold prescription refill data.
  • tblLTFU: The DEATH_R# fields now use CoDe codes for coding cause of death.
  • tblLAB:
    • Added codes for Gamma-glutamyltransferase and Prothrombin rate.
  • tblLAB_VIRO:
    • Changed code for "Other" of field VS_T to value 9.
    • Added "HBVACIGM", "HBVACIGG", "HCVBD" and "HDVA" codes for VS_ID field.
  • tblLAB_RES, tblLAB_RES_LVL_1, tblLAB_RES_LVL_2 and tblLAB_RES_LVL_3:
    • Renamed SAMP_ID to TEST_ID, as it gives a better description of what the values should encode.
  • tblLAB_RES:
    • Added a VIRUSTYPE variable allowing to distinguish HIV- and HCV-resistance tests.
    • Added recommended HIV-1 subtype codes and HCV geno- and subtype codes.
  • tblLAB_RES_LVL_3:
    • ATC_CODE replaces ART_ID as HCV medication in tblMED may be encoded.
  • tblDIS:
    • Added optional DIS_ED field for the end date of the disease.
  • tblMED:
    • Added MED_RS describing the reason for stopping the treatment; needed for HCV.
  • tblAE:
    • Added a number of codes for AE_ID: ANG, ASCI, AVN, BYP, CERC, END, FIBS, FRA, HEP, HESY, LAC, LIVB, OESO, PAN and PERI.
  • QA checks have been extended and updated where necessary.

Version 1.50

  • Added the pediatric tables: tblPREG, tblPREG_OBS, tblPREG_OUT, tblDELIVERY_MUM, tblDELIVERY_CHILD, tblNEWBORN and tblNEWBORN_ABNORM.
  • Added new table tblSAMPLES which holds information regarding sample storage.
  • tblART: Updated list of drugs

Version 1.30

  • tblART: Updated list of drugs
  • tblAE:
    • added EVENT_ID as unique identifier and link to detailed tables for each event (see 1) – this replaces the optional AE_NO field.
    • added AE_SPEC to further specify an event by coding
    • a series of basic verification fields have been added to allow for tracking of event status for source documentation availability, verification of documentation (through monitoring) and final approval of the event.
    • in AE_R_Y - Relation to treatment: added more detailed codes.
  • tblLAB: added several codes for various biomarker tests.
  • tblLAB_CD4: added CD4_U as optional fields to discriminate between CD4% and CD4 cell count, so that the tblLAB_CD4 table can hold both types of measurements.
  • tblLAB_VIRO: added several codes for various virology and serology tests.
  • CaseDefinitionsupdated with end stage renal disease, chronic liver disease and non-AIDS defining malignancies

1:Detailed table definitions for the D:A:D events are available at ​http://www.cphiv.dk/HICDEP/Documents/tabid/159/Default.aspx

Version 1.25

  • tblART: Updated list of drugs
  • tblMED: Updated list of drugs
  • tblDIS:
    • Changed wording for CANO to ‘Candidiasis, oesophageal, bronchi, trachea, or lungs’
    • Added COCC - Coccidioidomycosis, disseminated or extrapulmonary
  • tblLAB: Added LAB_ST as additional field to code for type of specimen used for the measurement
  • tblLAB_CD4: Added CD4_U as additional field so the table can hold both percentage and absolute CD4 measurements
  • tblLAB_RNA: Added RNA_UL (upper limit of detection) to the list of additional fields.
  • Added more viral assays to the list of RNA_T codes
  • tblLAB_VIRO: Added unit field to tblLAB_VIRO into the general format and VS_LL (lower limit of detection), VS_UL (upper limit of detection) and VS_T (type of test) and list of tests to the list of additional fields.
  • tblLTFU: Added DEATH_RC# to code for causal relation of the DEATH_R# code to the death in order to comply with CoDe and still maintain a format to be used for cohorts not using CoDe. ICD10_# fields have been moved to the list of additional fields.

Version 1.21

  • Added reasons for stopping treatment to table tblART_CODE_RS:
Code Coding for Reason of Stopping Treatment
1.1 Virological failure
1.2 Partial virological failure
1.3 Immunological failure – CD4 drop
1.4 Clinical progression
90 Side effects – any of the above but unspecified
90.1 Comorbidity
92.1 Simplified treatment available
92.2 Treatment to complex
92.3 Drug interaction
93.1 Structured Treatment Interruption (STI) – at high CD4
94.1 Non-compliance
96 Pregnancy
97 Study treatment

Version 1.2

  • added CaseDefinitions

Version 1.1

  • tblBAS:
    • The table was split into tblBAS and tblLTFU. tblLTFU holds data on death and drop-out
    • Renamed LOS_Y to LOSS_Y
    • Renamed GAI_Y to GAIN_Y
  • tblLAB_BLP:
    • Renamed table to tblLAB_BP
    • Renamed BLP_D to BP_D
    • Renamed BLP_SYS to BP_SYS
    • Renamed BLP_DIA to BP_DIA
    • Renamed BLP_U to BP_U

Version 1.00

  • tblBas:
    • Renamed BIRTHDAY to BIRTH_D
    • Renamed FIRSTVIS to FRSVIS_D
    • Renamed REC_ART to RECART_Y
  • tblLAB:
    • LAB_U: has been dropped – please use the “unit codes/strings” as that is a safer way to code/represent the units – prefixing all “unit codes/strings” with a numeric value should however make analysis easier.
  • tblLAB_VIRO:
    • New table added to capture mainly hepatitis measurements/tests
  • tblLAB_RES:
    • SEQ_DT was added to capture the time of sequencing in order to facilitate quality assurance of the data for contamination that might have happened during the sequencing.
  • tblLAB_RES_LVL1:
    • Renamed SEQ_ST to SEQ_STAR
    • SEQ_STOP: Added to the table to specify at which position in the sequence the sequencing was terminated
  • tblLAB_RES_LVL2:
    • The table has been optimised for ease of analysis so that the mutation codes have been split into their components of amino acid position, sub position for insertions and 4 our more fields for mixtures of amino acids found in the sample

Version 0.50 and 0.90

First public versions that incorporated comments and corrections received from attendees at the 7th International Workshop on HIV Observational Databases, March 29th-30th 2003, Fiuggi, Italy and Stephen Hart.

Version 0.38

Version presented at 7th International Workshop on HIV Observational Databases, March 29th-30th 2003, Fiuggi, Italy