CODING MANAGEMENT
(Part II)
Recap
• Coding• What are Coding Dictionaries• Structure of Dictionaries• Different Forms of Coding• How Organizations Handle Coding?• Challenges• Dictionary Types• Process of Coding
Dictionary Types
COSTART --Coding Symbols for a Thesaurus of Adverse Reaction Terms
MedDRA--Medical Dictionary for Regulatory Activities
WHODRL -- World Health OrganizationDrug Reference List
WHOART-- World Health Organization Adverse Reactions Terminology
ICD-9-CM-- International Classificationof Diseases, Ninth Revision, Clinical Modification
MedDRA
– Medical Dictionary for Regulatory Activities
– Replaces WHO-ART, ICD-CM, CoSTART
WHO Drug
– Replaces BNF dictionary
What Does The Future Hold For What Does The Future Hold For Dictionaries?Dictionaries?
What is the impact of MedDRA and WHO-Drug?– No misspelled verbatim terms– Industry standards– Outside governance w/ periodic
updates
What Does The Future Hold For What Does The Future Hold For Dictionaries?Dictionaries?
ICD-9-CMICD-9-CM________________________________________
InternationalInternationalClassification ofClassification ofDiseases - 9th EditionDiseases - 9th EditionClinically ModifiedClinically Modified________________________________
- Cause of Death - Cause of Death - Medical History- Medical History- Concomitant Illness- Concomitant Illness- Primary Diagnosis- Primary Diagnosis- Secondary - Secondary DiagnosisDiagnosis- Subject Drug - Subject Drug IndicationsIndications-Non Drug Non Drug TreatmentTreatment
WHO - ARTWHO - ART__________________________________________
World HealthWorld Health Organization - Organization - Adverse Reaction Adverse Reaction TerminologyTerminology
________________________- - Adverse EventsAdverse Events
• SeriousSerious• Non-SeriousNon-Serious-Maps to COSTART -Maps to COSTART for for reporting purposesreporting purposes
BNFBNF______________________________________
British British National National FormularyFormulary
______________________________
- Study Drugs- Study Drugs- Concomitant - Concomitant Drugs Drugs -Previous DrugsPrevious Drugs
A Sample of Encoding level terms from this category shows:
M = Terms accepted as misspellings
Q = Terms that no longer encode
Terms that no longer encode (Q’d terms) are terms that were acceptable at
one time, but due to convention changes are no longer acceptable. Or they can be
terms which were accepted in error and need to be “shut off”.
Central & Periph. Nerv. Central & Periph. Nerv.
HeadacheHeadache
Head discomfortHead discomfort
Head painHead pain
Head pressureHead pressure
AutoencodingAutoencoding
–Once data from the case report form has Once data from the case report form has been entered and verified, the Data been entered and verified, the Data Manager begins an electronic autoencoding Manager begins an electronic autoencoding process which compares the text of the process which compares the text of the investigator term in the clinical trial investigator term in the clinical trial database to the text strings stored in the database to the text strings stored in the dictionary databases. When an dictionary databases. When an exactexact match occurs, the code from the term in the match occurs, the code from the term in the dictionary database is automatically entered dictionary database is automatically entered into the clinical trial database. The term is into the clinical trial database. The term is considered “autoencodedconsidered “autoencoded”.”.
How Does The Dictionary Process How Does The Dictionary Process work?work?
Three potential dispensations can be Three potential dispensations can be assigned:assigned:
• AcceptedAccepted: the term is added to the central dictionaries : the term is added to the central dictionaries and will be available for autoencoding the next time and will be available for autoencoding the next time that that exactexact term exists in a database. term exists in a database.
• Accepted as a Misspelled TermAccepted as a Misspelled Term: the term is added to : the term is added to the central dictionaries with a flag of “M” indicating it the central dictionaries with a flag of “M” indicating it is an unambiguous misspelled term. These terms will is an unambiguous misspelled term. These terms will autoencode. autoencode.
• RejectedRejected: as is, term cannot be accepted into the : as is, term cannot be accepted into the central dictionaries. More information is neededcentral dictionaries. More information is needed..
What Happens When A Term What Happens When A Term Doesn’t Autoencode?Doesn’t Autoencode?
Query Writing• Respell – Please correct the spelling of _ to _. Thank
you.
• Clarify as follows_. If reporting _ then please edit or provide a ref/copy of the label. Thank you. (QC:Ref…)
• Clarify as follows _. Are you reporting _? Or _? Or other? If so then please edit or provide a ref / copy of the label. Thank you.(QC: Ref ….)
• Clarify as follows_. Can’t find. Please edit to include accurate trade / ingredient name or provide a ref / copy of the label. Thank you.(QC: Ref ….)
Clarify as follows_. Multiple formulations available. Are you reporting….
Clarify as follows_. Please spell out the abbreviation XYZ . Thank you. (QC: Ref….)
Clarify as follows_. Please edit out symbols/characters from the term and edit as_. Thank you.
Multiple concepts for _. Please split the term ___ into ___ and ___. Thank you
Query Writing
WHO Drug Conventions
• Abbreviations - In general, abbreviations must be completely unambiguous to be coded. If a verbatim term consists only of an abbreviation, the abbreviation is acceptable only if it has one interpretation.
• Misspelled & References to Age/Dates/Years – Not Accepted.
• Foreign Drug spelling are accepted in Who Drug
• Symbols – ® , * , $, -- , @ Not Accepted (*context)
Drug vs. Non Drug - A Drug is swallowed, injected, infused, inhaled, inserted, applied, chewed,A Non
Drug is procedures, non-drug treatment, or devices, Radiotherapy. However, if a drug is named along
with a procedure, then code to the drug named.
Wound dressing/Bandage + Drug = Drug Wound dressing/Bandage - Drug = ALL OTHER
NON- THERAPEUTIC PRODUCTS
(promote healing through absorption) Wound
Dressing/Bandage(support, pressure, compression) = non-drug treatment
WHO Drug Conventions
Generic/Generic—Non-synonyms 1) Verbatim term: “Hydrochlorothiazide and
triamterene” Coding decision:
HYDROCHLOROTHIAZIDE/TRIAMTERENE2) Verbatim term:“Naproxen and misoprostol” Coding decision: Napratec3) Verbatim term:“Codeine and phenytoin” Coding decision:Split the term (There is not a multi-
ingredient entry for this verbatim term and the term cannot be referenced as a marketed combination.)
Generic/Generic----Synonyms 1) Verbatim term: “Paracetamol/Acetaminophen”
Coding decision: PARACETAMOL
Trade/Generic----Synonyms
1) Verbatim term: “Cephalexin—Keflex” Coding decision: KEFLEX
Trade/Generic----Non-synonyms 1) Verbatim term: “Advil - Metronidazole”
Coding decision: Split Trade/Trade----Non-synonyms
1) Verbatim term: “Advil/Tylenol” Coding decision:Split the term
Trade/Trade---synonyms 1) Verbatim term:“Datril/Tylenol” Coding decision:Split the term
18
MedDRA browser
Introduction to MedDRASystem Organ Class (SOC) Organization
The MedDRA Browser
Vertical & Horizontal Hierarchy Mode – Display Features
Includes 16,559 PT
“Repeats”*
Preferred Term (PT) 16,559
System Organ Class (SOC) 26
High Level Term (HLT) 1,681
High Level Group Term (HLGT) 332
Verbatim Term (VT) / (VTB)
Lower Level Term (LLT) / (LLTNC) 61,704*
MedDRA Hierarchy V 8.0
No of concepts (Terms)
Includes 16,559 PT “Repeats”*
Vertical Hierarchy Mode -Horizontal
Display Term Level Details
Horizontal Hierarchy Mode – Display Features
EXAMPLE: LLT SWELLING OF FEET
Searching
• Quick Search
• Search Results may be saved to Microsoft EXCEL
• Advanced Search
Search Types
Quick Search Types:-• Equal• Equal/Contains• Contains/AND• Contains/OR• Contains/Similar• Wild
Quick Search Example Retrieves No Results
• Enter diabete in the Term field• Select the Equal Search Type• Click on Quick Search
– Search retrieves no results– A message is displayed in the MedDRA Search Results window
Quick Search Example Retrieves Results
Example:• Enter typhoid fever in the Quick Search Term
field
• Select the Equal Search Type
• Click on Quick Search button– The results are displayed in the MedDRA
Search Results pop-up window
MedDRA Search Results Window
• View Horizontal Hierarchy of term
• Search results may be saved to Microsoft Excel
Search Results Displayed In Excel
To Save Search Results in EXCEL:• Click on File, Save As• Select the Save in drive• Enter a File name• Select Save as type Microsoft Excel Workbook• Click on Save