Draft Version 1.110

tblLAB_HCV

  • Added table

tblVIS_SUBS

  • Added table

tblART

  • Added new options to ART_ID
    • J05AF13
    • J05AG06
    • J05AR20
    • J05AR21
    • J05AR22
    • J05AR24
    • J05AR25
  • Added new options to ART_RS
    • 92.91 : Change to generic drug
    • 92.92 : Change to branded drug

tblBAS

  • Redesigned codes for ETHNIC
    • 100 = White/Caucasian
    • 110 = White, European
    • 200 = Black
    • 204 = Other Black
    • 210 = Sub-Saharan African
    • 220 = Caribbean
    • 230 = African-American
    • 250 = Black, African
    • 300 = Hispanic/Latinx
    • 400 = Asian
    • 410 = East Asian (e.g. Chinese, Japanese)
    • 411 = Chinese
    • 412 = Japanese
    • 420 = Southeast Asia (e.g. Thai, Vietnamese, Philippino)
    • 421 = Indian Subcontinent (Indian, Pakistani, Bangladeshi)
    • 430 = South Asian (e.g. Indian, Pakistani)
    • 800 = Other ethnic groups
    • 810 = Maghrebian
    • 820 = Middle East/Arab
    • 830 = Turkish
    • 840 = Roma people/Gypsy (whichever is term is acceptable)
    • 850 = Indigenous people from Americas or Alaska Native
    • 860 = Indigenous people from other continents/locations
    • 900 = Mixed race/ethnicity
    • 910 = Do not want to disclose
    • 980 = Prohibited
    • 999 = Unknown
  • Renamed GENDER to SEX

tblVIS

  • Renamed GENDER_ID to GENDER_IDENT
  • Added codes to GENDER_IDENT
    • 6 = Non-binary

tblCEP

  • Added new codes to CEP_ID
    • CTAB
    • ARFI
  • Added codes to CEP_SPEC, for CEP_ID = FRA
    • SKUL
    • FABO
    • COLB
    • SHOU
    • UPAR
    • LOAR
    • FING
    • RIB
    • TOSP
    • CESP
    • LUSP
    • FEM
    • HIP
    • LOLG
    • TOE
    • OTH
  • Added codes to CEP_V, for CEP_ID = FRA
    • 1 = Traumatic
    • 2 = Osteoporotic/Fragility
    • 3 = Pathologic

tblLAB_RES

  • Added new optional field TESTTYPE_M

tblLAB_VIRO

  • Added new codes to VS_T
    • 10 = Rapid diagnostic test -3rd generation [HIV]
    • 11 = Rapid diagnostic test -4th generation [HIV]
    • 12 = Self-test-oral [HIV]
    • 13 = Self-test-blood-based [HIV]
    • 14 = Immunoassay (EIA, CLIA, ECL) - 3rd generation [HIV]
    • 15 = Immunoassay (EIA,CLIA, ECL) plus p24 - 4th generation [HIV]
    • 16 = WB: Western blot/immunoblot [HIV]
    • 17 = NAT (Nucleic Acid Test) [HIV]

Previous versions

Version 1.100

tblART_MUM

  • Added table

tblART

  • Added new optional field ART_FORM
  • Added new optional field ART_COMB
  • Added new optional field ART_START_RS
  • Added coding table with reasons for medication start ART_START_RS

tblBAS

  • Removed field CENTER as it is available in

tblVIS

  • Added new optional field PROPH_Y Extended coding table of field MODE
  • Added Code 9 (sexual contact homo/hetero not specified)
  • Added Code 10 (sexual abuse)

tblCENTER

  • Added new optional field SURVEY_INTERNET
  • Added new optional field SURVEY_PAPER
  • Added new optional field LAST_REVIEWED_D tblDELIVERY_CHILD
  • Added new optional field CHILD_ENROL tblDELIVERY_MUM
  • Added new optional field ROM_DUR
  • Added new optional field ROM_DUR_A
  • Added new optional field DELIVERY_LOCATION
  • Added new optional field PLANNED_HOME
  • Added new optional field DELIV_ASSIST

tblDIS

  • Added new optional field DIS_OUTCOME
  • Added new optional field DIS_SITE
  • Added various codes to coding table of field DIS_ID

tblLAB

  • Added various codes to coding table of field LAB_ID
  • Added new optional field LAB_R
  • Added coding table for field LAB_ST

tblLAB_RES

  • Added new optional field PATHOGENTYPE

tblLAB_RES_LVL_3

  • Added new optional field RES_SCOR_ID

tblLAB_VIRO

  • Added new optional field VS_ST

tblLTFU

  • Added new optional field MOTHERDEATH_Y
  • Added new optional field MOTHERDEATH_D
  • Added new optional field FATHERDEATH_Y
  • Added new optional field FATHERDEATH_D

tblMED

  • Added new optional field MED_RS2
  • Added new optional field MED_RS3
  • Added new optional field MED_RS4
  • Added new optional field MEDSTART_RS
  • Added new optional field MED_DO
  • Added new optional field MED_FR
  • Added new optional field MED_DOT_Y

tblNEWBORN

  • Added new optional field ENTRY_PMTCT
  • Added new optional field BREASTFD_Y
  • Added new optional field BREASTFD_DUR

tblNEWBORN_ABNORM

  • Added IeDEA coding table for abnormalities
  • Added field ABNORM_T_S to distinguish new coding of abnormalities from old Hicdep-coding

tblPREG

  • Added new optional field EST_CONCEPT
  • Added new optional field PREG_TEST_D
  • Added new optional field NUM_FETUS
  • Added new optional field ULTR_3
  • Added new optional field ULTR_A_3

tblPREG_OUT

  • Added new optional field CHILD_HIV
  • Added new optional field CHILD_HIV_D
  • Added codes to field OUTCOM:
    • 4 = Born alive
    • 22 = Termination: method unknown

tblVIS

  • Added new optional field GENDER_ID
  • Added new optional field SCHOOL
  • Added new optional field SCHOOL_LVL
  • Added new optional field FEEDOTH_Y
  • Added new optional field CAREGIVER
  • Added new optional field BROUGHT_PATIENT
  • Added new optional field HIV_STATUS
  • Added new optional field STATUS_KNOWN


Added date precision annotation variables for many date variables (both existing and new ones above):

  • tblART: ART_SD_A, ART_ED_A
  • tblBAS: BIRTH_D_A, ENROL_D_A, RECART_D_A, AIDS_D_A
  • tblCANC: CANC_D_A
  • tblCENTER: LAST_REVIEWED_D_A
  • tbclDIS: DIS_D_A, DIS_ED_A
  • tblLAB: LAB_D_A
  • tblLAB_BP: BP_D_A
  • tblLAB_CD4: CD4_D_A
  • tblLAB_RES: SAMPLE_D_A, SEQ_DT_A
  • tblLAB_RNA: RNA_D_A
  • tblLTFU: DROP_D_A, DEATH_D_A, MOTHERDEATH_D_A, FATHERDEATH_D_A, L_ALIVE_D_A
  • tblMED: MED_SD_A, MED_ED_A
  • tblPREG: MENS_D_A, EST_CONCEPT_A, ANC_D_A, PREG_TEST_A
  • tblPREG_OUT: OUTCOME_D_A, CHILD_HIV_D_A

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 ‚Äčhttp://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 ac