Download Mentor-Protégé Approach in Training

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
MedDRA 9.0
PSI Proprietary
Mentor-Protégé Approach to
Training
NONE OF US ARE AS SMART
AS ALL OF US.
Japanese proverb
PSI Proprietary
MedDRA 9.0
Why MedDRA Training?
Only MedDRA-trained professionals/team can perform:
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Coding with accuracy and specificity
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Coding with consistency and uniformity
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Data summarization by Primary/secondary SOCs
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Comprehensive retrieval by medical topics (SMQs)
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Signal detection
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Case series definition….
MedDRA 9.0
PSI Proprietary
MedDRA Training: A Mentor-Protégé
Approach and Skill Maintenance Program
Initial exposure
Mentor-protégé phase
Coding team
Documentation
Summary
PSI Proprietary
MedDRA 9.0
MedDRA Training: Initial exposure
Objectives:
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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
PSI Proprietary
MedDRA 9.0
MedDRA Training: Initial exposure
Delivery Method:
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Computer based training (CBT)
Formal class presentation
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Generic content
Customized content according to audience
(investigators, statisticians…)
MedDRA 9.0
PSI Proprietary
MedDRA Training: A Mentor-Protégé
Approach and Skill Maintenance Program
Initial exposure
Mentor-protégé phase
Coding team
Documentation
Summary
MedDRA 9.0
PSI Proprietary
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”
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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”
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Motivated health care professional
MedDRA 9.0
PSI Proprietary
MedDRA Training:
Mentor-Protégé Phase
Objective of this phase: have the protégé be proficient in:
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Verbatim evaluation/extraction
Adherence to Coding Guidelines
MedDRA Coding with medical accuracy, specificity and consistency
Achieved by:
Formal Hands-on coding class
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Internal Coding tool access and use
Verbatim and narrative coding exercises
Certification program
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Development of protégé’s proficiency
Application and demonstration of skills
Metrics for evaluation
PSI Proprietary
MedDRA 9.0
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
PSI Proprietary
MedDRA 9.0
Hands-on Coding class
MedDRA content
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Scope
What is included
What is excluded
Granularity
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Structure
Hierarchy
Multiaxiality
Primary SOC
Secondary SOC assignment
Retrieval groupings (SMQs)
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Rules and conventions
PSI Proprietary
MedDRA 9.0
Hands-on Coding class
MedDRA Coding guidelines
 ICH-endorsed MedDRA Term Selection: Points to Consider
 Organization specific Coding Guidelines: Clinical/Pharmacovigilance
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’
PSI Proprietary
MedDRA 9.0
Hands-on Coding class
 MedDRA Coding techniques
“wakes up too early”
1. Search appropriate SOC for section
on sleep disorders, drill down from
HLGT to HLT to closest PT and finally
Top down approach LLT
“wakes up too early”
2. Search on text string %wake%;
examine all resulting LLT-PTs
Bottom up approach
“cancer related fever”
1. Search Neoplasm SOC for
appropriate section on cancer-related
complications, drill down from HLGT
Top down approach to HLT to closest PT and finally LLT
PSI Proprietary
MedDRA 9.0
Hands-on Coding class
 Explanation of a “thought process” used in finding the
most appropriate LLT in MedDRA
“adenomatous colonic polyp”
1.
2.
3.
Search for the entire verbatim
Define main medical concept
Repeat search
“red, itchy rash”
1.
2.
3.
Search for the entire verbatim
Define main medical concept
Repeat search
‘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
PSI Proprietary
MedDRA 9.0
Mentor-protégé phase:
Electronic Certification
Certification Program:
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Fine-tuning of coding skills
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Exercise program with increasing level of complexity
Application of clinical skills, verbatim assessment and
coding ability
Communication between Mentor and Protégé
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Protégé submits a processed record
Mentor feedback: validation as correct or constructive
observation
Protégé attempts until he/she ‘gets it right’
PSI Proprietary
MedDRA 9.0
Verbatim extraction
Stand-alone
criteria for a
verbatim
• Capturing all medically
significant information of the
event
• Application of Coding
guidelines
• Application of MedDRA
granularity
MedDRA 9.0
PSI Proprietary
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’
PSI Proprietary
MedDRA 9.0
Fine-tuning of coding skills (2)
• Medically correct
coding:
“vaginal bleeding”
• in a pregnant patient
• in a postmenopausal patient
• following a cervical biopsy
PSI Proprietary
MedDRA 9.0
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”
MedDRA 9.0
PSI Proprietary
Electronic Certification
‘
Protégé coding
MedDRA 9.0
PSI Proprietary
Electronic Certification
‘
Mentor feedback
MedDRA 9.0
PSI Proprietary
Electronic Certification
‘
Protégé coding correction
MedDRA 9.0
PSI Proprietary
Electronic Certification
Mentor feedback: record completed
‘
MedDRA 9.0
PSI Proprietary
Electronic Certification
Metrics
After successful Electronic Certification
program completion, Protégé graduates
to the Coding team
MedDRA 9.0
PSI Proprietary
MedDRA Training: A Mentor-Protégé
Approach and Skill Maintenance Program
Initial exposure
Mentor-protégé phase
Coding team
Documentation
Summary
PSI Proprietary
MedDRA 9.0
Coding team
Workflow:
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Coding
Coding Quality Control
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Overview of the entire team’s output
Real-time “mentoring” of coders by the QC team
Coding Quality Assurance: sample review
Synonym table maintenance
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Approval process for Verbatim-LLT additions
Periodic Synonym table review
Training material
MedDRA 9.0
PSI Proprietary
Coding team (2)
Coding skills maintenance program:
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MedDRA version changes training
Coding guidelines changes training
Focus on identified areas of concern
(emails, notices, white-board, meetings)
Continued coder education
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Internal presentations, trainings
Professional organizations: DIA and related training
courses, workshops, conferences
MedDRA 9.0
PSI Proprietary
MedDRA Training: A Mentor-Protégé
Approach and Skill Maintenance Program
Initial exposure
Mentor-protégé phase
Coding team
Documentation
Summary
MedDRA 9.0
PSI Proprietary
MedDRA Training: Documentation
Documentation of training (compliance)
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Training SOP (Mentoring phase and beyond)
Training checklist
Employee Training record and certificates
Continued education record
Documentation of MedDRA processing issues
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Material for training examples
Focus of output review
MedDRA 9.0
PSI Proprietary
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…