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TRAINING SOLUTIONS Pharmaceuticals | Healthcare PART II - DESIGN
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Systems Approach to Training Evaluate
Flexible, outcome-oriented system Instructional system shall determine needs and priorities, develop effective and effective solutions to achieving these needs, implement them competently, and asses how well the outcomes meet the specified needs.
Implement
Develop Design
Analyze 07/FEB/2018
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Corporate Training Manual becomes the input to the Design phase.
DESIGN Knowledge, skills, attitudes
Published materials
Sequence terminal learning objectives (TLO)
Target audience
Subject matter experts
Enabling learning objectives (ELO)
Methods of instruction
Learning analysis worksheet
Logical transitions from one skill to the next
Methods of evaluation
Individual training standard
Grouping based on shared elements
Gather data
Sustainment period
Sequencing: hierarchical, logical
Review students’ background
Standard & Conditions
Sequenced TLOs serve as a course structure
Summarize entry requirements
Test items
Target Audience
Learning Analysis
Who is coming for instruction? What are their Knowledge, Skills and Attitudes?
What will be taught, evaluated and how?
Sequence learning objectives What order shall the instruction follow to maximize resources and transfer of learning?
Learning objectives Test items
Target population description 07/FEB/2018
Methods & Media
Sequenced Terminal Learning Objectives 3
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Target population description Knowledge | Skills | Attitudes Minimum prerequisites of people coming for instruction
Determines selection of methods, media and evaluation •
Licensed physician
•
Research scientist
•
Nurse
•
Fresh graduate
Gather data about the job
Review student background
Sample TPD This Photo by Unknown Author is licensed under CC BY-NC-ND
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Herta Oberheuser, physician on trial for having conducted medical experiments on concentration camp prisoners. Nuremberg, Germany, August 1947. (USHMM)
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Attitudes matter
Science does indeed have an ethical dimension 07/FEB/2018
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This Photo by Unknown Author is licensed under CC BY-NC-ND
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Gather materials
Learning analysis
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Manuals
Determine training requirements
Regulations, SOPs
Analyze TPD
Subject matter experts’ input
Record task data
Learning Analysis Worksheet
Knowledge, Skills and Attitudes for each performance step
Index of individual training standards Description of individual components
Group KSAs Sequence groupings
Record learning analysis
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Whole to Part: Result first, then each step of the process Part to Whole:
Sequence KSA groupings
Step by step, to the final product
Sequence Knowledge, Skills & Attitudes
Simple-to-Complex: Present familiar or simple concepts first Complex-to-Simple: Large complex structure scaled down to more detail Chronological: Concepts and ideas presented as they occur Sequential: Procedures and steps as they occur Cause and effect:
Useful to form long-term memory Critical order: Actions sequenced in order of relative importance Known-to-unknown:
Some familiarity with action without specifics 07/FEB/2018
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Behavior | Condition | Standard Basis for Measurement Focus for both Instructor and Student DEVELOP LEARNING OBJECTIVES
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Components of a learning objective BEHAVIOR
CONDITION
STANDARD
1 action verb & 1 object
Aiding: reference materials, tools, equipment, job aids
Describes level of proficiency the student has to achieve
Free of ambiguity Observable & measurable Bloom’s Taxonomy verbs Simple, clear & concise Realistic performance in the instructional environment
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Limiting: specific resource or information not available Environmental:
Location & facilities Social context – teams
Implied: LO as described implies the existence of equipment and resources needed to operate it
Completeness: quantitative statement that indicates acceptable standard Accuracy: use references that describe acceptable standard Time: specify min/max time required to complete the task Realistic: Time, accuracy and completeness criteria allow for successful completion 9
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CONDITIONS from standard to extreme Severe
weather Hackers, ransomware, DDoS Criminal activity & organized crime Civil disruption & conflict War, natural disaster Prioritize
critical functions Roles & Responsibilities Backup solutions (paper-based) Limit improvisation and human error 07/FEB/2018
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Constructing terminal learning objectives Record Individual Training Standard Task / Event
Is the Condition OK?
Combine elements Construct TLO Modify Condition to reflect setting
nope
yepper Is the Standard OK?
Modify Standard to reflect setting
nope
yepper Is the Behavior OK?
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nope
Downgrade justification 11
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Enabling learning objectives Grouping of KSAs
Draft behavior statement
Modify draft behavior
Write condition to reflect setting
Write standard to reflect setting
Combine elements in ELO
Pick a verb Knowledge
•Arrange •Define •Organize •Label •Group •Pick •List •Memorize •Quote •Transfer •Identify
Comprehension
Comprehension
Comprehension
translation
interpretation
Extrapolation
•Change •Reword •Render •Convert •Expand •Transform •Alter •Vary •Restate •Qualify
•Infer •Define •Explain •Construe •Outline •Annotate •Expound
•Project •Propose •Advance •Contemplate •Submit •Advance •Calculate •Scheme •Contrive
Application
•Relate •Utilize •Solve •Adopt •Employ •Sketch •Apply •Choose •Exploit •Use •Operate
Analysis
•Breakdown •Uncover •Dissect •Examine •Divide •Simplify •Reason •Include •Audit •Scrutinize •Screen
Synthesis
•Create •Combine •Build •Compile •Reorganize •Develop •Produce •Compose •Cause •Effect •Generate
Evaluation
•Judge •Decide •Prioritize •Appraise •Assess •Rank •Weigh •Accept •Determine •Classify •Accept/reject
Levels of cognitive domain 07/FEB/2018
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Writing Terminal Learning Objectives Record Behavior from Manual
•Copy behavior from the Manual •Learning Objective Worksheet
Record Condition and Standard from Manual
•Copy Condition and Standard from the Manual •Modifications
•Modify TLO in the same manner
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Compare resources against task list
•Accommodate Constraints of instructional setting •Downgrade justifications •Request additional resources • • TIME • MANPOWER • FACILITIES • EQUIPMENT • BUDGET • SAFETY
Determine evaluation methods
•PSYCHOMOTOR •Evaluation of the process, the result or both
•COGNITIVE •Evaluation written or oral •Provision for remediation
Complete TLO
•Write TLO in a form of a complete sentence •“Given an ICSR with completed MedDRA coding, assessment and medical review, enter the ICSR in the database with the aid of reference SOP”
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Develop test items Analyze Learning Objective
•Did the student acquire the required KSAs? •Criterion-based test items •Knowledge-based or performance-based test •Conditions & Scenarios •How well is the test performed
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Determine type of test item
•Performance-based: •Subject knowledge & the ability to perform • Assess the process • Assess the product •Knowledge-based tests • True/false • Multiple choice • Matching • Listing • Fill-in-the-blank • Short answer • Labeling • Essay
Write test items
Record test items
•Test construction occurs in the DEVELOP phase
•Learning Objective Worksheet (LOW)
•Performance objective •List steps, activities, behaviors (process) & parameters (product) •Arrange & reorder steps/activities •Review the checklist •Instructions for the evaluator •Instructions for the student •Performance checklist
•Master Lesson File (MLF) •Enter test items in training management system for automated grading
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Media
Select Media and Methods
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Printed materials
Review media considerations
Erase boards, turn chart
Target population description
Models, mock-ups
Learning objective
Actual item or object
Class size
Overhead projectors & slides
Resources
Audiotapes, video, film
Learning styles
Computer-based training
Interactive video
Select media
Virtual reality
Record instructional media
Interactive multimedia
Teleconference
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Method selection
Coaching
Case study
Simulations (roleplaying, games)
Field trips
Practical application (individual or group)
Application
Guided discussion
Non-directed discussion
Questioning (Socratic method)
Self-paced (computer-based)
Self-study (reading)
Interaction
Demonstration
Indirect discourse (Panel discussion)
NI – comprehension level EI – Higher level 1 – Individual class L – large class (20+) M – medium class (13-24) S – small class (2-12)
Lecture
Presentation
Factors & Constraints Instructor expertise
NI
NI
EI
EI
EI
EI
n/a
EI
EI
NI
EI
EI
EI
L/M
L/M
S
1
1
S/M
M
S/M
1
S
S/M
S/M
1/S
Evaluation inherent in method
N
N
Y
N
Y
Y
N
N
Y
N
Y
Y
Y
Responsive to individual needs
N
N
Y
Y
Y
Y
Y
Y
Y
N
Y
Y
Y
Class size
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Demonstration
Self-study (reading)
Self-paced (computer-based)
Questioning (Socratic method)
Non-directed discussion
Guided discussion
Practical application (individual or group)
Field trips
Simulations (roleplaying, games)
Case study
Coaching
Application
Indirect discourse (Panel discussion)
Interaction
Lecture
Presentation
Higher levels
X
X
X
X
OK
OK
X
X
HR
X
HR
HR
HR
Comprehension
HR
HR
X
OK
HR
HR
X
HR
OK
X
OK
OK
X
Knowledge
HR
OK
X
HR
HR
X
X
X
OK
OK
X
X
X
Higher level
X
X
HR
X
OK
X
X
X
HR
X
OK
X
HR
Lower level
X
X
HR
X
OK
X
X
X
HR
X
OK
X
HR
Higher level
X
X
X
X
X
X
X
X
X
OK
HR
HR
X
Lower level
HR
HR
X
OK
OK
OK
OK
HR
OK
HR
HR
OK
HR
X – Not Recommended OK – Recommended HR – Highly Recommended
Cognitive domain
Psychomotor
Affective
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Sequence TLO Ensures efficiency, proper transition and structured learning RELATIONSHIPS Grouping TLOs •
Same object
•
Same condition
Relationships in sequencing •
Dependent
•
Supportive
•
Independent
•
Conflicting
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SEQUENCING STEPS
Group TLOs based on shared elements
Determine relationships between TLOs
Arrange TLOs based on their relationships
DESIGN PHASE OUTPUTS Target Population Description Learning Objectives (ELO, TLO)
Test items Methods and Media Sequenced TLOs
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Training design
Training that is responsive to the organization’s needs improves staff competence and increases the organization’s ability to adapt to constantly changing environment in a proactive manner.
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ARETE-ZOE, as a consultancy, provides solutions to complex problems in the high stakes and high consequence environment of Global Pharmaceuticals, including clinical research, healthcare informatics, and public health. We blend established, Pharma sector methodologies, innovation, and adaptations/transfers from other sectors to identify and resolve consequential practices that pose risk and often result in avoidable patient casualty. However, we are specifically, not a patient advocacy group but believe in optimizing organizational effectiveness and that smart business is agile, competitive and profitable, while intrinsically safe, secure, and resilient. We work within a global context because transnational interests influence national circumstances and choices at point of prescription.
ARETE-ZOE, provides full spectrum organizational and operational risk management consultancy. Our published materials provide a glimpse of some aspects of our services to demonstrate both knowledge and ongoing participation within the Pharmaceutical Industry. Our analysis and consultancy includes all channels of misuse, diversion, counterfeiting and illicit exploitation of pharmaceuticals, medical devices, and precursor chemicals. Our advisement is to manufactures, jurisdictional entities, insurers, legislators, litigators, patients, and health care providers. This scope also frequently segues into the nexus of crime and terrorism as significant influencers that undermine sector integrity differentiated from other criminal activity. Obviously, vulnerability assessment, information collection management and intelligence production supporting decision-making for risk reduction and interventions are routinely within the scope of our services as well as design and implementation of operational control measures.
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