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
SUBTYPE Modified 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_T New 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.
tblREFILL
created 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 variable allowing to distinguish HIV- and HCV-resistance tests.
Added recommended and .
tblLAB_RES_LVL_3
ATC_CODE replaces ART_ID as HCV medication in tblMED may be encoded.
tblDIS
Added optional field for the end date of the disease.
tblMED
Added describing the reason for stopping the treatment; needed for HCV.
tblAE
Added a number of codes for : 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
updated with end stage renal disease, chronic liver disease and non-AIDS defining malignancies
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