Medical Coding - clinical trial

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Medical Coding - clinical trial Powered By Docstoc
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Coding Dictionaries
WHOART - World Health Organization Adverse Reaction Terminology COSTART - FDA‟s Coding Symbols for a Thesaurus of Adverse Reaction Terms MedDRA - Medical Dictionary for Regulatory Activities Terminology ICD9CM - International Classification of Diseases 9th Revision Clinical Modification WHODD - World Health Organization Drug Dictionary

Coding Dictionaries
WHOART, COSTART and MedDRA are used for coding of adverse events  WHODD is used for coding of concomitant medication  ICD9CM and MedDRA are used for coding of medical history


Coding Dictionaries


 

Inventory of Coding Dictionaries  V:MedLib/Inventory/MedLib Dictionary Inventory Each coding dictionary is stored under it‟s own directory under V:MedLib Under the directory of the dictionary is the source, and the version  e.g. WHODD2000Q2 was supplied by Bayer (source) and is stored as follows  V:MedLib/WHODD/Bayer/WHODD2000Q2

Coding Dictionaries Structure
Each dictionary has it own unique structure  Each coding dictionary has a hierarchical structure


How Does The Dictionary Process work?


Autoencoding
–Once data from the case report form has been entered and verified, the Data Manager begins an electronic autoencoding process which compares the text of the investigator term in the clinical trial database to the text strings stored in the dictionary databases. When an exact match occurs, the code from the term in the dictionary database is automatically entered into the clinical trial database. The term is considered “autoencoded”.

What Happens When A Term Doesn’t Autoencode?


Three potential dispensations can be assigned:
• Accepted: the term is added to the central dictionaries and will be available for autoencoding the next time that exact term exists in a database. • Accepted as a Misspelled Term: the term is added to the central dictionaries with a flag of “M” indicating it is an unambiguous misspelled term. These terms will autoencode.

• Rejected: as is, term cannot be accepted into the central dictionaries. More information is needed.

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”.

Head discomfort

Headache Head pain

Central & Periph. Nerv.

Head pressure

Coding Dictionaries Structure


Example: WHO-ART consists of the following levels
 Included

Terms  Preferred Term  High Level Term  System Organ Class

Hierarchical Structure
System Organ Class PSYCHIATRIC DISORDERS

High Level Term PERSONALITY DISORDER

Preferred Term EUPHORIA

Low Level Term EUPHORIA

Low Level Term FEELING HIGH

Hierarchical Structure - Example WHO-ART


Included Terms
 Lowest

level in the hierarchy  Synonymous terms or closely related terms  Used when coding - the included terms are searched for a term matching the verbatim term (CRF Term)  Used for autoencoding  Example: CRF Term “Feeling High” matches with Included Term “Feeling High”  CRF Term “Mood Elevation” matches with Included Term “Mood Elevation Inappropriate”  CRF Term “Exaggerated well-being feeling” matches with Included Term “EXAGGERATED WELL-BEING”


Hierarchical Structure - Example WHO-ART


Preferred Terms
 Unique

description of a symptom, disease or diagnosis  Included terms that are synonymous or closely related terms maps to a specific preferred term

Hierarchical Structure - Example WHO-ART
CRF Term Feeling High Patient Very Happy Mood Elevated Exaggerated Feeling of Well-Being Match Included Term in WHO-ART Feeling High Feeling Happy Inappropriately Mood Elevation Inappropriate Exaggerated Well-Being Preferred Term Euphoria Euphoria Euphoria Euphoria

Hierarchical Structure - Example WHO-ART


High Level Terms
 PT‟s

are classified according to High Level Terms  Related PT‟s are grouped together  For Example:
 Pt‟s

„Depersonalization, Emotional Lability, Euphoria, Hysteria, Personality Disorder, are all classified as “Personality Disorder”  Pt‟s „Cystitis‟, „Pyelonephritis‟, „Renal Abscess‟, „Urinary Tract Infection‟, „Renal Tract Inflammation‟, „Bladder Discomfort‟ are all classified as „Renal Tract Inflammation‟  Pt‟s „Hepatitis Infectious‟, „Hepatitis Viral‟, are classified as „Hepatitis‟

Hierarchical Structure - Example WHO-ART


System Organ Class
 Highest

level in the hierarchy  All preferred terms are linked to a System Organ Class  A preferred term can link to a maximum of three SOC‟s; SOC I, SOC II, SOC III  SOC I is the most relevant  For example:  The PT‟s „Euphoria‟, „Emotional Lability‟, „Depression‟, „Confusion‟ are classified and „Psychiatric Disorders‟  The Pt‟s „Urinary Tract Infection‟, „Cystitis‟, „Urinary Incontinence‟, „Urinary Retention‟ are classified as „Urinary System Disorders‟  The Pt‟s „Hypertension‟, „Hypotension‟, are classified as „Cardiovascular Disorders, General‟

Structure of WHO-ART Code


Code
 Code

consists of 24 digits  Usually the first 7 digits are used in coding  By means of these 7 digits links to the higher levels can be obtained

Structure of WHO-ART Code
Code: 0294 001 3 0294 0600 0700 1230 Position (1-4) 0294 -Record Number
 Unique

4 digit code assigned to a Preferred Term  Included terms of the same Preferred Term have the same record number

Position (5-7) 001 Number
 Define

-Sequence

whether preferred term or an included term  PT‟s have a Sequence Number of 001, and Included terms have a Sequence Number of 003, 004 etc.

Structure of WHO-ART Code
Code: 0294 001 Position (8) 3


3 0294 0600 0700 1230 -Check Digit
-High Level Link

WHO use only The High Level Link is the record number of the PT that is the higher level term of a specific PT

Position (9-12) 0294


Position (13-16) 0600 Position (17-20) 0700 Position (21-24) 1230

-System Organ Class I -System Organ Class II -System Organ Class III

Structure of WHO-ART Code


For “GI Haemorrhage” (0294 001 3 0294 0600 0700 1230)



“GI Haemorrhage” is a preferred term identified by Seq No 001 Included Terms of “GI Haemorrhage” are identified by the same Record Number (0294) and Sequence Number 003, 004, 005:
 “Gastrointestinal

Tract Bleed Nos” code 0294 003;  “Haemorrhage Gastric” code 0294 004  “Haemorrhage Pharyngeal” code 0294 005


High Level Term of “GI Haemorrhage” :

High Level Link Code is 0294  0294 is record number of “GI Haemorrhage”  High Level Term is “GI Haemorrhage”


Structure of WHO-ART Code


For “GI Haemorrhage” (0294 001 3 0294 0600 0700 1230)
 System

Organ Class

Code 0600 GASTRO-INTESTINAL SYSTEM DISORDERS  SOC Code 0700 LIVER AND BILIARY SYSTEM DISORDERS  SOC Code 1230 PLATELET,BLEEDING & CLOTTING DISORDERS

 SOC

Structure of WHO-ART Code


For “Acne” (0001 001 7 0007 0100)  ACNE is a preferred term identified by Sequence number 001  Included terms of ACNE identified by the same Record number (0001) and Sequence Numbers 003, 004, 005, 006, 007 are “Acneiform Dermatitis”, “Rash Acneiform”, “Acne Cystic”, “Acne Pustular”, “Acne Aggravated”  High Level Term of Acne  High Level Link Code of “Acne” is 0007  0007 is the record number of “Dermatitis”  High Level Term is “Dermatitis”
 SOC

Code 0100” SKIN AND APPENDAGES DISORDERS”

ICD9CM
Definition: International Classification of Diseases 9th Revision Clinical Modification  Classification of diseases and surgical procedures


ICD9CM


Hierarchy
 Main

Classes/Chapters denoting a body system of type of disease  Sections: Groups of 3-digit codes  Categories: 3-digit code  Subcategories: 4-digit codes  Subclassifications: 5-digit codes

ICD9CM


Code exists of 3, 4 or 5 digits
 Codes

for diseases exist of 3 digits with a maximum or 2 decimal digits. E.g. 250.00  Codes for surgeries exist of 2 digits with a maximum of 2 decimal digits e.g. P01.02
  

ICD9CM code should be used at their highest level of specificity Always use the 5-digit code if there is one 3 and 4 digit codes should only be used if there is not a more specific code

ICD9CM Examples


CRF Term “Vibrio Cholerae” coded to “Cholera Due To Vibrio Cholerae (001.0)


Main Class:


 

Section:
Category: Subcategory:

INFECTIOUS AND PARASITIC DISEASES (Codes from 001139) INTESTINAL INFECTIOUS DISEASES (Codes from 001 - 009) Cholera (Code 001) Cholera Due To Vibrio Cholerae (001.0)

ICD9CM Examples


CRF Term “Parkinsonism” coded to “Paralysis agitans (code 332.0)
 

Main Class ORGANS Section NERVOUS Category Subcategory

 

NERVOUS SYSTEM AND SENSE (codes from 320 - 326) HEREDITARY AND DEGENERATIVE DISEASES OF THE CENTRAL SYSTEM (codes from 330 - 337) Parkinson‟s disease (332) Paralysis agitans (332.0)

ICD9CM Code


CRF Term “Diabetes Mellitus” coded to “Diabetes Mellitus Without Mention of Complications, Type II or Unspecified Type, Not Stated As Uncontrolled” (code 250.00)


Main Class


  

Section GLANDS Category Subcategory Subclassifications MENTION

ENDOCRINE, NUTRITIONAL AND METABOLIC DISEASES (240 - 279) DISEASES OF OTHER ENDOCRINE (250 - 259) DIABETES MELLITUS (250) DIABETES MELLITUS WITHOUT OF COMPLICATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED (250.00)

WHO-DRL
DEF: World Health Organization Drug Reference List  International Classification of Drugs

 Proprietary

drug names, active ingredients and chemical substances are provided with unique reference numbers

WHO-DRL


Drugs are classified and grouped together
 according

to active ingredients  Anatomical-Therapeutical-Chemical Classification (ATC -Classification)

WHO-DRL


Drugs containing the same active ingredients are assigned a „Preferred Name‟
 Usually

the active ingredient is the „Preferred

Name‟  Example:
The

„Preferred Name‟ for Disprin and Aspirin is „Acetylsalicylic Acid‟

WHO-DRL


Multiple-ingredient drug
 The

first reported drug name, with a specific ingredient combination, is chosen as the „Preferred Name‟  Example:
 the

first reported drug to WHODD with the combination paracetamol and codeine was „PANADEINE CO‟  PANADEINE CO is the „Preferred Name‟ for paracetamol and codeine combination preparations.

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. Abbreviations with multiple meanings are acceptable if modifiers clarify the meaning. Misspelled & References to Age/Dates/Years – Not Accepted. Foreign Drug spelling are accepted in Who Drug Symbols – ® , * , $, -- , @ Not Accepted (*context)

  

WHO Drug Conventions
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 = Move

Generic/Generic—Non-synonyms 1) Verbatim term: “Hydrochlorothiazide and triamterene” Coding decision: HYDROCHLOROTHIAZIDE/TRIAMTERENE 2) Verbatim term:“Naproxen and misoprostol” Coding decision: Napratec 3) 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

WHO-DRL
When coding an eleven digit code is assigned to the drug name recorded in the CRF  The 11-digit code consists of:

 Drug

Record Number - First 6 digits  Sequence Number 1 - Digit 7 and 8  Sequence Number 2 - Digit 9, 10 and 11


This 11-digit code is all that is needed to establish links to the other levels

WHO-DRL
Code: 000001 01 002 4 T 68 10 MSD 01 854


Position (1 - 6)
 

- Record Number (000001)

Unique 6-digit code assigned to the „Preferred Name‟ Drugs with the same „Preferred Name‟ have the same record number (6-digits)

 

Position (7 - 8)


- Sequence Number 1 (01) - Sequence Number 2 (002)

Differentiate between salt/esters of the same compound

Position (9 - 11)



Differentiate between trade names with the same active ingredients A „Preferred Name‟ always has a Sequence Number 2 of 001

WHO-DRL
Code: 000001 01 002 4 T 68 10 MSD 01 854
        

Position (12) Position (13) Position (14 - 15) Position (16 - 19) Position (20-24) Position (25 - 26) Position (27) Position (28 - 30) Position (31 - 75)

- Check Digit (4) - Designation (T) - Source Year (68) - Source Code (10) - Company Code (MSD) - Number of Ingredients (01) - Salt/Ester Code - Year, Quarter (854) - Drug Name (Aldomet)

Coding with WHO-DRL


 



Example: Ampicillin Ampicillin…………………. 000005 01 001 Ampicillin Sodium………… 000005 02 001 Penbritin…………………… 000005 01 005 000005 is the record number of all preparations containing Ampicillin Seq No 1 -02 identifies Ampicillin Sodium as an Ampicillin salt Seq No 2 -005 identifies Penbritin as a trade name of Ampicillin

Coding with WHO-DRL


Example: Ampiclox
Ampiclox……………. Sinteclox…………….. Cloxamin……………. 001903 01 001 001903 01 002 001903 01 004

Record number 001903 indicates that Ampiclox, Sinteclox, Cloxamin contain the same ingredients  Active ingredients are ampicillin and cloxacillin


WHO-DRL: ATC Code
ATC Code = Anatomical-TherapeuticChemical Classification System  Drugs can have more than one ATC Code


WHO-DRL: ATC Code
5-level hierarchy
Level 1……………... Level 2……………... Level 3……………... Sub Level 4……………… Group Level 5……………… Anatomical Main Group Therapeutical Main Group Pharmacological-Therapeutical Group Chemical-Therapeutical Sub Chemical Defined Substance

ATC Code
ATC Code of Paracetamol: N02BE
N (1st character)……………… Level 1………….. Nervous System N02 (1st 3 characters)………... Level 2………….. Analgesics N02B (1st 4 characters)………. Level 3………….. Other Analgesics and Antipyretics N02BE (1st 5 characters)…...… Level 4………….. Anilides

ATC Code for Aldomet (Anti-Hypertensive Medication): C02AB
C (1st character)……………… Level 1………………Cardiovascular System C02 (1st 3 characters)………… Level 2……………… Antihypertensives C02A (1st 4 characters)………. Level 3………………Antiadrenergic agents, centrally acting C02AB (1st 5 characters)…… Level 4……………… Methyldopa

ATC Code
 

Aspirin has a choice of 3 ATC Codes according to indication - N02BA, B01AC, A01AD N02AB: Salicylic Acid and Derivatives
N N02 N02B Level 1 Level 2 Level 3 Nervous System Analgesics Other Analgesics and Antipyretics Salicylic Acid and

N02BA Derivatives
 B Organs B01 B01A B01AC

Level 4

B01AC: Platelet Aggregation Inhibitors Exl. Heparin
Level 1 Blood and Blood Forming

Level 2 Level 3 Level 4

Antithrombotic Agents Antithrombotic Agents Platelet Aggregation Inhibitors Excl. Heparin

ATC Code


A01AD: Other Agents for Local Oral Treatment
A A01 A01A A01AD Level 1 Level 2 Level 3 Level 4 Alimentary Tract and Metabolism Stomatological Preparations Stomatological Preparations Other Agents for Local Oral Treatment



Concomitant Medication

COSTART


Hierarchy
 Reported

Term  English Term  Sub-Body System  Primary Body System

COSTART
  





The English Term is equivalent to the Preferred Term of other coding dictionaries Each English Term is assigned a COSTART Term COSTART term is equivalent to the code, assigned to the Preferred Term, of other dictionaries Reported Terms are equivalent to the Included Terms of other dictionaries COSTART term is a word code and not a numeric code

COSTART


CRF Term “Heart Irregular”:
   

Is assigned the Reported Term “Heart Irregular” Costart Code for Reported Term “Heart Irregular” is Arrhythmia English Term for Costart Code “Arrhythmia” is “Arrhythmia” Body System/Sub-Body System Code is CV/CARD/ARR

CV system is  CARD/ARR System is


Indicates that the primary body Cardiovascular System Indicates that the Sub-Body Cardiac Arrhythmia



Other reported terms with the Costart Code “Arrhythmia”


„Heartbeats Irregular”, “Heartbeats Skipped” etc.

COSTART


CRF Term “Malignant Neoplasm of Brain”
 Is

assigned the Reported Term “Brain Neoplasm Malignant”  Costart Code for “Brain Neoplasm Malignant” is “Carcinoma”  English Term for Costart Code “Carcinoma” is “Carcinoma”  Body System/Sub-Body System Code is Body/Gen
 Body

Indicates that the primary body system is “Body as a Whole”  Gen Indicates that the sub-body system is “General”

MedDRA browser

55

Introduction to MedDRA
System Organ Class (SOC) Organization

MedDRA
Def: Medical Dictionary for Regulatory Activities  How Large?

 26

System Organ Classes  56 000 terms arranged in a 5-level hierarchy

MedDRA


Five-Level Hierarchy
 Lowest

Level Term (LLT)  Preferred Term (PT)  High Level Term (HLT)  High Level Group Term (HLGT)  System Organ Class (SOC)

MedDRA Hierarchy
System Organ Class PSYCHIATRIC DISORDERS High Level Group Term Mood Disorders and Disturbances NEC

High Level Term Emotional or Mood Disturbances NEC

Preferred Term Euphoric Mood

Lowest Level Term Excitement Excessive

Lowest Level Term Elation Inappropriately

Lowest Level Term Feeling Happy Inappropriately

MedDRA Codes
Each MedDRA term assigned and 8-digit numeric code  The code is non-expressive  Initially assigned alphabetically by term starting with 10000001

 New

terms are assigned sequentially



Codes are never reused

MedDRA
Each Preferred Term is assigned a primary System Organ Class  Many preferred terms have a secondary System Organ Class  A preferred term can link to a specific System Organ Class via only one path

 PT

- HLT - HLGT- SOC I  PT - HLT - HLGT - SOCII

MedDRA


Example of Preferred Term with more than one SOC - Somnolence
PT Somnolence HLT Disturbance in Consciousness Dyssomnias HLGT Neurological Signs and Symptoms SOC Nervous System Disorders Sleep Disorders and Psychiatric Disturbances Disorders

LLT Drowsiness

Drowsiness

Somnolence

A preferred term can only have one primary system organ class  The primary system organ class is Nervous System Disorders


The MedDRA Browser

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 ….)

Query Writing
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 references to Dates/years/age and edit as_. Thank you.
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


				
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