MedDRA 9.0 PSI Proprietary MedDRA Training: A Mentor-Protégé Approach and Skill Maintenance Program Mark Vieder, R.Ph. PSI International, Inc DIA Annual.

MedDRA 9.0 PSI Proprietary

MedDRA Training: A Mentor-Protégé Approach and

Skill Maintenance Program

Mark Vieder, R.Ph.

PSI International, Inc

DIA Annual Meeting

June 20, 2006, Philadelphia


Mentor-Protégé Approach to Training

NONE OF US ARE AS SMART

AS ALL OF US.

Japanese proverb


Why MedDRA Training?

Only MedDRA-trained professionals/team can perform:

– Coding with accuracy and specificity

– Coding with consistency and uniformity

– Data summarization by Primary/secondary SOCs

– Comprehensive retrieval by medical topics (SMQs)

– Signal detection

– Case series definition….


MedDRA Training: A Mentor-Protégé Approach and Skill Maintenance Program

Initial exposure Mentor-protégé phase

Coding team

Documentation

Summary


MedDRA Training: Initial exposure

Objectives: – Outline the data input/output path– Discuss MedDRA content, structure and

challenges– Discuss criteria for an acceptable verbatim– Introduce the concept of “Coding

Guidelines”– Provide a coding and retrieval overview


MedDRA Training: Initial exposure

Delivery Method: – Computer based training (CBT)– Formal class presentation

• Generic content

• Customized content according to audience (investigators, statisticians…)



Initial exposure

Mentor-protégé phase Coding team

Documentation

Summary


MedDRA Training: Mentor-Protégé Phase

Mentor: - “trusted counselor or teacher who gives another person help

and advice over a period of time and teaches them how to do their job”

• Senior coder and trainer (internal or external)• Clinical experience• Knowledge of SOPs, coding guidelines, workflow, management

structure

Protégé: - “a person who receives support and protection from an

influential patron who furthers the protégé's career”

• Motivated health care professional


MedDRA Training: Mentor-Protégé Phase

Objective of this phase: have the protégé be proficient in:• Verbatim evaluation/extraction• Adherence to Coding Guidelines• MedDRA Coding with medical accuracy, specificity and consistency

Achieved by:

Formal Hands-on coding class • Internal Coding tool access and use• Verbatim and narrative coding exercises

Certification program • Development of protégé’s proficiency• Application and demonstration of skills• Metrics for evaluation


Mentor-protégé phase: Hands-on Coding Class

MedDRA content

ICH-endorsed MedDRA Coding guidelines

MedDRA Coding techniques Top down approach Bottom up approach

Examples using organization specific data and coding guidelines Clinical safety perspective (verbatim string) Drug safety (pharmacovigilance) reports Synonym table maintenance


Hands-on Coding class MedDRA content• Scope

What is included What is excluded Granularity

• Structure Hierarchy Multiaxiality Primary SOC Secondary SOC assignment

Retrieval groupings (SMQs)

• Rules and conventions


Hands-on Coding class

Diagnosis with signs/symptoms ‘Gastroenteritis with severe diarrhea’

Provisional diagnosis with signs/symptoms ‘Diarrhea probably due to gastroenteritis’

‘Diarrhea due to gastroenteritis or to the medication’

Combination terms: criteria for splitting ‘Neck pain due to MVA’

‘Nausea and vomiting’

Coding of investigational results ‘Potassium 7.1’

Infection site vs. microorganism ‘Lung infection pseudomonal’

Modification of a pre-existing condition ‘Aggravated lung infection pseudomonal’

MedDRA Coding guidelines ICH-endorsed MedDRA Term Selection: Points to Consider Organization specific Coding Guidelines: Clinical/Pharmacovigilance



“cancer related fever”

Top down approach

1. Search Neoplasm SOC for appropriate section on cancer-related complications, drill down from HLGT to HLT to closest PT and finally LLT

MedDRA Coding techniques

“wakes up too early”

Top down approach

1. Search appropriate SOC for section on sleep disorders, drill down from HLGT to HLT to closest PT and finally LLT

“wakes up too early”

Bottom up approach

2. Search on text string %wake%; examine all resulting LLT-PTs



‘Patient was admitted to ER after having taken Drug X. Diagnosed with tubular nephropathy as a result of drug toxicity.’

LLT Nephropathy toxic

OR

LLT Nephropathy tubular

LLT Drug toxicity

Explanation of a “thought process” used in finding the most appropriate LLT in MedDRA

“adenomatous colonic polyp” 1. Search for the entire verbatim

2. Define main medical concept

3. Repeat search

“red, itchy rash” 1. Search for the entire verbatim

2. Define main medical concept

3. Repeat search


Mentor-protégé phase: Electronic Certification

Certification Program:– Fine-tuning of coding skills

• Exercise program with increasing level of complexity

• Application of clinical skills, verbatim assessment and coding ability

– Communication between Mentor and Protégé• Protégé submits a processed record

• Mentor feedback: validation as correct or constructive observation

• Protégé attempts until he/she ‘gets it right’


Verbatim extraction

• Capturing all medically significant information of the event

• Application of Coding guidelines

• Application of MedDRA granularity

Stand-alone criteria for a verbatim


Fine-tuning of coding skills

• Coding of ‘similar’ verbatims:

‘Open wound on left foot’

‘Wound on foot’

‘Infected wound on foot’

OR

‘Foot puncture wound’

‘Stepped on a nail’

‘Foot injury due to a nail’


Fine-tuning of coding skills (2)

• Medically correct coding:

“vaginal bleeding”

• in a pregnant patient

• in a postmenopausal patient

• following a cervical biopsy


Fine-tuning of coding skills (3)

• Specific Coding guidelines:

• “Bacterial pneumonia Aug. 2000”

• “Insomnia due to cystitis”

• “Increased liver enzymes, jaundice, hospitalized to R/O Hepatitis”


Electronic Certification Protégé coding ‘


Electronic Certification Mentor feedback ‘


Electronic Certification Protégé coding correction ‘


Electronic Certification Mentor feedback: record completed

‘


Electronic Certification Metrics

After successful Electronic Certification program completion, Protégé graduates to the Coding team



Initial exposure

Mentor-protégé phase

Coding team Documentation

Summary


Coding team

Workflow:– Coding– Coding Quality Control

• Overview of the entire team’s output

• Real-time “mentoring” of coders by the QC team

– Coding Quality Assurance: sample review– Synonym table maintenance

• Approval process for Verbatim-LLT additions

• Periodic Synonym table review

• Training material


Coding team (2)

Coding skills maintenance program:• MedDRA version changes training

• Coding guidelines changes training

• Focus on identified areas of concern (emails, notices, white-board, meetings)

Continued coder education• Internal presentations, trainings

• Professional organizations: DIA and related training courses, workshops, conferences



Initial exposure

Mentor-protégé phase

Coding team

Documentation Summary


MedDRA Training: Documentation

Documentation of training (compliance)– Training SOP (Mentoring phase and beyond)– Training checklist– Employee Training record and certificates– Continued education record

Documentation of MedDRA processing issues– Material for training examples– Focus of output review


Summary

Good training program:– Experience based learning process– Individual support through a Mentor/Group– Documentation

Benefits:– Reliable, dependable data input/output– Regulatory compliance

Risks:– Only if the training is lacking…

MedDRA 9.0 PSI Proprietary MedDRA Training: A Mentor-Protégé Approach and Skill Maintenance Program Mark Vieder, R.Ph. PSI International, Inc DIA Annual.

Documents

specificity coding

mentorprotg phase mentor

concept of coding guidelines

mentorprotg phase objective

psi international

philadelphia slide

evaluation slide

retrieval overview slide