Hicdep.org

Wikiprint Book
Title: Project-specific merger
Subject: HICDEP specification for requested tables
Version: 1.0
Date: 2011-02-14
Table of Contents
tblAE - Adverse Events
AE_ID field
Coding Table: Pregnancy-related adverse events Coding Table: Early childhood-related adverse events Case Definitions for AE_ID
tblART - Antiretroviral treatment
ART_ID field
ART_RS field
tblAE - Adverse Events
holds type and date of adverse events including serious non-AIDS conditions Core fields
Note: Fields marked bold form the unique identifier for a record of the table.
Field name
Description
Unique Event Identifier (foreign key to the Code to identify patient (Cohort Patient ID) whether the source documentation is available date for source documentation verification Please see the HICDEP website for examples of detailed AE tables for the events listed in 3.16.2 below. Data format is available in the HICDEP DAD Additional fields
Field name
Description
QA Checks
Crosstable
Description
AE_ID field
Coding Table
Code (AE_ID)
Adverse Event
Coding Table: Pregnancy-related adverse events
Adverse Event
Disseminated intravascular coagulation (DIC) Severe anemia requiring blood transfusion Coding Table: Early childhood-related adverse events
Developmental delay
Other neurological symptoms (use with AE_DESCRIP) Other abnormal findings (use with AE_DESCRIP) Case Definitions
Case Definitions for
HICDEP Code
ICD-10 codes
Adverse Event
Definition
serum lipase, radiological findings.
tblART - Antiretroviral treatment
holds type of antiretroviral drug, start and stop dates and reason for stopping Core fields
Note: Fields marked bold form the unique identifier for a record of the table.
Field name
Description
Additional fields
Depending on the aim of the study it might be needed to gather both the dosage and the frequency of the dosage taken. However many cohorts do not collect this date and thus these fields are optional.
Field name
Description
It may also be necessary to record the start and end time: Field name
Description
QA Checks
Crosstable
Description
ART_ID field
Code representing the antiretroviral treatment Coding Table
A set of extended ATC codes are being presented here in order to code both more specific on subtypes of the drugs, e.g. saquinavir hard and soft gel, but also to enable coding of drugs that are at their trial stage and have not yet been assigned an ATC code. To do this the drug will be assigned the code elements as far down the levels as possible. Given two examples to illustrate this: This will ensure the fidelity needed to distinguish between hard and soft gel and not specified, but also for analysis easily include all records which coding starts with J05AE01, regardless if the drug is hard or soft gel.
Code (Extended ATC Codes)
Anti-Retroviral Drugs
Trizivir (Zidovudine/Lamivudine/Abacavir) Douvir-N (Zidovudine/Lamivudine/Nevirapine) Atripla (Emtricitabine/Tenofovir/Efavirenz) ART_RS field
Coding Table
Reason for Stopping Treatment
Treatment failure (i.e. virological, immunological, and/or clinical failure Toxicity, predominantly from abdomen/G-I tract Toxicity, predominantly from nervous system Toxicity, predominantly from endocrine system Side effects - any of the above but unspecified Availability of more effective treatment (not specifically failure or side effect Structured Treatment Interruption (STI) - at high CD4 Patient's wish/decision, not specified above Physician's decision, not specified above Although most reasons mentioned above could be coded in ICD-10 codes, it is still certain that many reasons will never be defined in terms of ICD-10 (STI, physicians and patients decision), so to avoid a mixture of two different coding systems it is advised to go with the above list and build upon that for

Source: http://hicdep.org/raw-attachment/wiki/HowtoPrintABook/Project-specific_merger.pdf