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Simulation Research:
Improving Rigor, Impact, and
Methodology
May 8, 2016
Glasgow, UK
IPSSW Pre-Conference Workshop
International Network for Simulation-based Pediatric Innovation, Research and Education
Introduction / Faculty
• Ralph MacKinnon
• Todd Chang
• Vinay Nadkarni
• David Kessler
Disclosures
• No relevant financial conflicts of interest
• INSPIRE receives funding/support from
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
Mission
We aim to improve the delivery of medical care to acutely ill children
by answering important research questions pertaining to resuscitation,
technical skills, behavioral skills, debriefing and simulation-based
education
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
Who are you?
• Where do you work with Simulation?
• What is your simulation experience?
• What is your research experience?
International Network for Simulation-based Pediatric Innovation, Research and Education
Learning Objectives
• Define the 2 types of simulation-based research
• Evaluate characteristics of a simulation-based research
question or protocol that are conducive to quality
research and output
• Identify 6 specific challenges in simulation-based
research that threaten rigor and quality of research
output
Objectives
1. Develop a study design using simulation as the
subject of research
2. Develop a study design using simulation as an
investigative methodology
3. Use Reporting Guidelines to improve study
methodology
International Network for Simulation-based Pediatric Innovation, Research and Education
Schedule
International Network for Simulation-based Pediatric Innovation, Research and Education
Didactic Discussion Small group work Break
Closing Discussion & Networking
Objectives
1. Develop a study design using simulation as the
subject of research
2. Develop a study design using simulation as an
investigative methodology
3. Use Reporting Guidelines to improve study
methodology
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
2 Types of Simulation Research
Research subject
(e.g. Team training)
Research method
(e.g. Test new defibrillator)
International Network for Simulation-based Pediatric Innovation, Research and Education
1: Simulation as the research subject
• Is simulation an effective training methodology?
• How do we maximize effects on patient outcomes?
2: Simulation as the research method
• Leverages standardization of simulation
• Questions that might not be safe, feasible, ethical, timely in traditional
research
Simulation as the subject of
research
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
INSPIRE Research Themes
Simulation as the subject
Debriefing
Develop/assess/implement effective techniques for debriefing
real/sim events
IPE, Teamwork,
Communication
Develop/assess/implement effective techniques for team
training
Procedural,
Psychomotor Skills
Develop/assess/implement effective techniques for skills
development retention
Simulation as the subject
• Research examining whether or not specific
features of simulation experiences are effective
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
Simulation as the subject
#1 start with strong conceptual model
What we know…
• 609 studies
• 23% RCT’s
• 12% multicenter studies
• 5% reported patient and/or
healthcare outcomes
• Sim is an effective educational
intervention compared to no
intervention
International Network for Simulation-based Pediatric Innovation, Research and Education
Pediatric Research
• 57 studies
• 1/3 RCT
• compare sim to no
intervention
• Large pooled effective size
• Knowledge
• Skills in simulation
• Time to completion
• < 10% on patient outcome
International Network for Simulation-based Pediatric Innovation, Research and Education
2 Lessons
International Network for Simulation-based Pediatric Innovation, Research and Education
1. Avoid the null comparison
• (Don’t compare to no intervention)
International Network for Simulation-based Pediatric Innovation, Research and Education
Varying Instructional Design
1. Feedback ***
2. Repetitive Practice ***
3. Distributed Practice
4. Curriculum Integration
5. Clinical variation
6. Range of difficulty
7. Individualized learning
8. Multiple learning strategies
9. Defined Outcomes
10. Valid simulator
International Network for Simulation-based Pediatric Innovation, Research and Education
What examples of Instructional
Design Features have you
investigated?
Discussion 1
2 Lessons
International Network for Simulation-based Pediatric Innovation, Research and Education
2. Measure patient outcomes
• (Or at least provider behavior)
Knowledge/skills
Attitudes/perceptions
Learners’ satisfaction/reaction
Yadley 2011, BEME 2005, Miller 1990, Kirkpatrick 1967
Δ practice
Δ behavior
Knowledge/skills
Attitudes/perceptions
Learners’ satisfaction/reaction
Yadley 2011, BEME 2005, Miller 1990, Kirkpatrick 1967
Popul-
ation
Patient
Δ practice
Δ behavior
Knowledge/skills
Attitudes/perceptions
Learners’ satisfaction/reaction
Yadley 2011, BEME 2005, Miller 1990, Kirkpatrick 1967
Framing your Research Outcomes
• Goal of medical education
• To transmit knowledge, impart skills, and inculcate
the values of medicine
that will improve health outcomes
Cooke, Irby, O’Brien. Carnegie Foundation Report: Educating Physicians: A call for reform of
medical school and residency. 2010
International Network for Simulation-based Pediatric Innovation, Research and Education
Selecting outcomes
• Important to patient
• Measurable
• Dependent on provider skills/behaviors
• Quality
• Satisfaction, comfort
• Procedure related **
• Success/failure
• Complications (Erb’s Palsy, Line Infections)
• Survival
• Cardiac resuscitation, obstetrics, NICU
International Network for Simulation-based Pediatric Innovation, Research and Education
INSPIRE Examples
International Network for Simulation-based Pediatric Innovation, Research and Education
Infant Lumbar Punctures
• Essential pediatric procedure
• Decreasing experience
• Novice success rate 35%
• Bench top simulator
• Low cost
• Easy to use
Auerbach et al Pediatric Emergency Care 2013, Gaies Pediatrics 2007
International Network for Simulation-based Pediatric Innovation, Research and Education
Infant Lumbar Punctures
• Instructional Design principles:
• Distributed Practice (JITT)
• Repeated Practice
• Defined Outcomes
• Outcomes selected:
• Clinical Lumbar Puncture success
International Network for Simulation-based Pediatric Innovation, Research and Education
Research Question
• Population
• Intervention
• Comparison
• Outcome
International Network for Simulation-based Pediatric Innovation, Research and Education
Research Question
• P – 1st year residents (‘interns’)
• I – Mastery Learning LP Training + Just-in-Time
Training on LP Simulator just prior to clinical LP
• C – Mastery Learning LP Training only
• O – Clinical LP success rate
International Network for Simulation-based Pediatric Innovation, Research and Education
Auerbach et al, Pediatric Emergency Care 2013
Overall Performance Score
International Network for Simulation-based Pediatric Innovation, Research and Education
Let’s design a Research Project:
Simulation as the subject
Small Group 1
Objectives
1. Develop a study design using simulation as the
subject of research
2. Develop a study design using simulation as an
investigative methodology
3. Use Reporting Guidelines to improve study
methodology
International Network for Simulation-based Pediatric Innovation, Research and Education
Simulation as an investigative
methodology
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
INSPIRE Research Themes
Simulation as the method
Technology
Develop/assess/implement novel technologies designed to
improve processes of care and pediatric patient outcomes
Acute Care and
Resuscitation
Develop/assess/implement novel techniques for improving care
of pediatric patients
Human Factors
Assess the role of human factors when providing care to
pediatric patients
Patient Safety
Explore the key variables that influence patient safety and
assess strategies to mitigate
Simulation as the method
• The simulated environment is used as an
experimental model to study factors affecting
human and systems performance in healthcare.
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
Why use simulated instead of real scenarios
• Standardization of “noise”
• Patient- age, clinical status, parent actions
• Individuals- experience, stress, fatigue
• Team- structure, numbers
• Environment- structure, distractions, noise
• Technology- equipment availability, size, safety
• Ask questions that might not be safe, feasible, ethical,
timely in traditional research
Threats to internal validity
International Network for Simulation-based Pediatric Innovation, Research and Education
Threats to validity
• Educator training
• Simulator Selection
• Scenario Design
• Confederates
• Realism (physical, conceptual and emotional)
• Debriefing
• Video Capture and Review
• Study Outcomes
Cheng et al, Pediatrics, 2014
• ADD SLIDES ON EDUCATIONAL DESIGNS- e.g.
solomon 4, cluster randomized etc…(martin’s
paper, selin workshop)
• Ethics- rct not always possible. (perfume
example)
What examples of Threats to
Validity have you encountered?
Discussion 2
INSPIRE Examples
International Network for Simulation-based Pediatric Innovation, Research and Education
Technology
• A QCPR simulator was
used to show that
Feedback Devices
improved CPR
performance
International Network for Simulation-based Pediatric Innovation, Research and Education
Systems/Human Factors
• Individuals
• Teams
• Environments
• Technological Factors
• Systems Factors
• Patient Factors
International Network for Simulation-based Pediatric Innovation, Research and Education
SEIPS 2.0. Ergonomics . 2013 November ; 56(11) Holden, Carayon et al
International Network for Simulation-based Pediatric Innovation, Research and Education
SEIPS 2.0. Ergonomics . 2013 November ; 56(11) Holden, Carayon et al
International Network for Simulation-based Pediatric Innovation, Research and Education
New Environments
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
Safety / Quality
• In-situ simulation
• Mobile unit brought into work environment
• Use real life equipment in “context”
• Work with real life team
• Identify latent safety threats
• Provider level - insufficient staffing/training
• Systems level - missing/broken equipment
International Network for Simulation-based Pediatric Innovation, Research and Education
Direct comparison: same patient at different
hospital
Crash Testing, not Normal Testing
• Identify and remediate threats to safety
• Active
• Latent: unrecognized errors in design or organization
International Network for Simulation-based Pediatric Innovation, Research and Education
Let’s design a Research Project:
Simulation as the method
Small Group 2
Objectives
1. Develop a study design using simulation as the
subject of research
2. Develop a study design using simulation as an
investigative methodology
3. Use Reporting Guidelines to improve study
methodology
International Network for Simulation-based Pediatric Innovation, Research and Education
Reporting Guidelines
• Standardized reporting will enhance quality of studies and assist journal
reviewer/editors
• Explanation and elaboration document will support implementation of
reporting guidelines
• Reporting guidelines currently under review
• Eventual adoption for author guidelines
International Network for Simulation-based Pediatric Innovation, Research and Education
Reporting Guidelines
• Extensions to prospective trial design:
• CONSORT (randomized-control)
• STROBE (observation cohort)
International Network for Simulation-based Pediatric Innovation, Research and Education
How do we use Reporting Guidelines?
International Network for Simulation-based Pediatric Innovation, Research and Education
Let’s review our Research
Project: Using Reporting
Guidelines
Small Group 3
Objectives
1. Develop a study design using simulation as the
subject of research
2. Develop a study design using simulation as an
investigative methodology
3. Use Reporting Guidelines to improve study
methodology
International Network for Simulation-based Pediatric Innovation, Research and Education
What changes will you be making?
International Network for Simulation-based Pediatric Innovation, Research and Education
What changes will you be making?
International Network for Simulation-based Pediatric Innovation, Research and Education
International Network for Simulation-based Pediatric Innovation, Research and Education
Questions?
www.inspireSim.com
International Network for Simulation-based Pediatric Innovation, Research and Education

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IPSSW Pre-Conference Workshop 7 (2016, Glasgow)

  • 1. Simulation Research: Improving Rigor, Impact, and Methodology May 8, 2016 Glasgow, UK IPSSW Pre-Conference Workshop
  • 2. International Network for Simulation-based Pediatric Innovation, Research and Education Introduction / Faculty • Ralph MacKinnon • Todd Chang • Vinay Nadkarni • David Kessler
  • 3. Disclosures • No relevant financial conflicts of interest • INSPIRE receives funding/support from International Network for Simulation-based Pediatric Innovation, Research and Education
  • 4. International Network for Simulation-based Pediatric Innovation, Research and Education Mission We aim to improve the delivery of medical care to acutely ill children by answering important research questions pertaining to resuscitation, technical skills, behavioral skills, debriefing and simulation-based education
  • 5. International Network for Simulation-based Pediatric Innovation, Research and Education
  • 6. International Network for Simulation-based Pediatric Innovation, Research and Education Who are you? • Where do you work with Simulation? • What is your simulation experience? • What is your research experience?
  • 7. International Network for Simulation-based Pediatric Innovation, Research and Education Learning Objectives • Define the 2 types of simulation-based research • Evaluate characteristics of a simulation-based research question or protocol that are conducive to quality research and output • Identify 6 specific challenges in simulation-based research that threaten rigor and quality of research output
  • 8. Objectives 1. Develop a study design using simulation as the subject of research 2. Develop a study design using simulation as an investigative methodology 3. Use Reporting Guidelines to improve study methodology International Network for Simulation-based Pediatric Innovation, Research and Education
  • 9. Schedule International Network for Simulation-based Pediatric Innovation, Research and Education Didactic Discussion Small group work Break Closing Discussion & Networking
  • 10. Objectives 1. Develop a study design using simulation as the subject of research 2. Develop a study design using simulation as an investigative methodology 3. Use Reporting Guidelines to improve study methodology International Network for Simulation-based Pediatric Innovation, Research and Education
  • 11. International Network for Simulation-based Pediatric Innovation, Research and Education 2 Types of Simulation Research Research subject (e.g. Team training) Research method (e.g. Test new defibrillator)
  • 12. International Network for Simulation-based Pediatric Innovation, Research and Education 1: Simulation as the research subject • Is simulation an effective training methodology? • How do we maximize effects on patient outcomes? 2: Simulation as the research method • Leverages standardization of simulation • Questions that might not be safe, feasible, ethical, timely in traditional research
  • 13. Simulation as the subject of research International Network for Simulation-based Pediatric Innovation, Research and Education
  • 14. International Network for Simulation-based Pediatric Innovation, Research and Education INSPIRE Research Themes Simulation as the subject Debriefing Develop/assess/implement effective techniques for debriefing real/sim events IPE, Teamwork, Communication Develop/assess/implement effective techniques for team training Procedural, Psychomotor Skills Develop/assess/implement effective techniques for skills development retention
  • 15. Simulation as the subject • Research examining whether or not specific features of simulation experiences are effective International Network for Simulation-based Pediatric Innovation, Research and Education
  • 16. International Network for Simulation-based Pediatric Innovation, Research and Education Simulation as the subject
  • 17. #1 start with strong conceptual model
  • 18. What we know… • 609 studies • 23% RCT’s • 12% multicenter studies • 5% reported patient and/or healthcare outcomes • Sim is an effective educational intervention compared to no intervention International Network for Simulation-based Pediatric Innovation, Research and Education
  • 19. Pediatric Research • 57 studies • 1/3 RCT • compare sim to no intervention • Large pooled effective size • Knowledge • Skills in simulation • Time to completion • < 10% on patient outcome International Network for Simulation-based Pediatric Innovation, Research and Education
  • 20. 2 Lessons International Network for Simulation-based Pediatric Innovation, Research and Education 1. Avoid the null comparison • (Don’t compare to no intervention)
  • 21. International Network for Simulation-based Pediatric Innovation, Research and Education
  • 22. Varying Instructional Design 1. Feedback *** 2. Repetitive Practice *** 3. Distributed Practice 4. Curriculum Integration 5. Clinical variation 6. Range of difficulty 7. Individualized learning 8. Multiple learning strategies 9. Defined Outcomes 10. Valid simulator International Network for Simulation-based Pediatric Innovation, Research and Education
  • 23. What examples of Instructional Design Features have you investigated? Discussion 1
  • 24. 2 Lessons International Network for Simulation-based Pediatric Innovation, Research and Education 2. Measure patient outcomes • (Or at least provider behavior)
  • 26. Δ practice Δ behavior Knowledge/skills Attitudes/perceptions Learners’ satisfaction/reaction Yadley 2011, BEME 2005, Miller 1990, Kirkpatrick 1967
  • 27. Popul- ation Patient Δ practice Δ behavior Knowledge/skills Attitudes/perceptions Learners’ satisfaction/reaction Yadley 2011, BEME 2005, Miller 1990, Kirkpatrick 1967
  • 28. Framing your Research Outcomes • Goal of medical education • To transmit knowledge, impart skills, and inculcate the values of medicine that will improve health outcomes Cooke, Irby, O’Brien. Carnegie Foundation Report: Educating Physicians: A call for reform of medical school and residency. 2010 International Network for Simulation-based Pediatric Innovation, Research and Education
  • 29. Selecting outcomes • Important to patient • Measurable • Dependent on provider skills/behaviors • Quality • Satisfaction, comfort • Procedure related ** • Success/failure • Complications (Erb’s Palsy, Line Infections) • Survival • Cardiac resuscitation, obstetrics, NICU International Network for Simulation-based Pediatric Innovation, Research and Education
  • 30. INSPIRE Examples International Network for Simulation-based Pediatric Innovation, Research and Education
  • 31. Infant Lumbar Punctures • Essential pediatric procedure • Decreasing experience • Novice success rate 35% • Bench top simulator • Low cost • Easy to use Auerbach et al Pediatric Emergency Care 2013, Gaies Pediatrics 2007 International Network for Simulation-based Pediatric Innovation, Research and Education
  • 32. Infant Lumbar Punctures • Instructional Design principles: • Distributed Practice (JITT) • Repeated Practice • Defined Outcomes • Outcomes selected: • Clinical Lumbar Puncture success International Network for Simulation-based Pediatric Innovation, Research and Education
  • 33. Research Question • Population • Intervention • Comparison • Outcome International Network for Simulation-based Pediatric Innovation, Research and Education
  • 34. Research Question • P – 1st year residents (‘interns’) • I – Mastery Learning LP Training + Just-in-Time Training on LP Simulator just prior to clinical LP • C – Mastery Learning LP Training only • O – Clinical LP success rate International Network for Simulation-based Pediatric Innovation, Research and Education
  • 35.
  • 36.
  • 37.
  • 38. Auerbach et al, Pediatric Emergency Care 2013 Overall Performance Score International Network for Simulation-based Pediatric Innovation, Research and Education
  • 39. Let’s design a Research Project: Simulation as the subject Small Group 1
  • 40. Objectives 1. Develop a study design using simulation as the subject of research 2. Develop a study design using simulation as an investigative methodology 3. Use Reporting Guidelines to improve study methodology International Network for Simulation-based Pediatric Innovation, Research and Education
  • 41. Simulation as an investigative methodology International Network for Simulation-based Pediatric Innovation, Research and Education
  • 42. International Network for Simulation-based Pediatric Innovation, Research and Education INSPIRE Research Themes Simulation as the method Technology Develop/assess/implement novel technologies designed to improve processes of care and pediatric patient outcomes Acute Care and Resuscitation Develop/assess/implement novel techniques for improving care of pediatric patients Human Factors Assess the role of human factors when providing care to pediatric patients Patient Safety Explore the key variables that influence patient safety and assess strategies to mitigate
  • 43. Simulation as the method • The simulated environment is used as an experimental model to study factors affecting human and systems performance in healthcare. International Network for Simulation-based Pediatric Innovation, Research and Education
  • 44. International Network for Simulation-based Pediatric Innovation, Research and Education Why use simulated instead of real scenarios • Standardization of “noise” • Patient- age, clinical status, parent actions • Individuals- experience, stress, fatigue • Team- structure, numbers • Environment- structure, distractions, noise • Technology- equipment availability, size, safety • Ask questions that might not be safe, feasible, ethical, timely in traditional research
  • 45. Threats to internal validity International Network for Simulation-based Pediatric Innovation, Research and Education
  • 46. Threats to validity • Educator training • Simulator Selection • Scenario Design • Confederates • Realism (physical, conceptual and emotional) • Debriefing • Video Capture and Review • Study Outcomes Cheng et al, Pediatrics, 2014
  • 47. • ADD SLIDES ON EDUCATIONAL DESIGNS- e.g. solomon 4, cluster randomized etc…(martin’s paper, selin workshop) • Ethics- rct not always possible. (perfume example)
  • 48. What examples of Threats to Validity have you encountered? Discussion 2
  • 49. INSPIRE Examples International Network for Simulation-based Pediatric Innovation, Research and Education
  • 50. Technology • A QCPR simulator was used to show that Feedback Devices improved CPR performance International Network for Simulation-based Pediatric Innovation, Research and Education
  • 51. Systems/Human Factors • Individuals • Teams • Environments • Technological Factors • Systems Factors • Patient Factors International Network for Simulation-based Pediatric Innovation, Research and Education
  • 52. SEIPS 2.0. Ergonomics . 2013 November ; 56(11) Holden, Carayon et al International Network for Simulation-based Pediatric Innovation, Research and Education
  • 53. SEIPS 2.0. Ergonomics . 2013 November ; 56(11) Holden, Carayon et al International Network for Simulation-based Pediatric Innovation, Research and Education
  • 54. New Environments International Network for Simulation-based Pediatric Innovation, Research and Education
  • 55.
  • 56. International Network for Simulation-based Pediatric Innovation, Research and Education Safety / Quality • In-situ simulation • Mobile unit brought into work environment • Use real life equipment in “context” • Work with real life team • Identify latent safety threats • Provider level - insufficient staffing/training • Systems level - missing/broken equipment
  • 57. International Network for Simulation-based Pediatric Innovation, Research and Education Direct comparison: same patient at different hospital
  • 58. Crash Testing, not Normal Testing • Identify and remediate threats to safety • Active • Latent: unrecognized errors in design or organization International Network for Simulation-based Pediatric Innovation, Research and Education
  • 59. Let’s design a Research Project: Simulation as the method Small Group 2
  • 60. Objectives 1. Develop a study design using simulation as the subject of research 2. Develop a study design using simulation as an investigative methodology 3. Use Reporting Guidelines to improve study methodology International Network for Simulation-based Pediatric Innovation, Research and Education
  • 61. Reporting Guidelines • Standardized reporting will enhance quality of studies and assist journal reviewer/editors • Explanation and elaboration document will support implementation of reporting guidelines • Reporting guidelines currently under review • Eventual adoption for author guidelines International Network for Simulation-based Pediatric Innovation, Research and Education
  • 62. Reporting Guidelines • Extensions to prospective trial design: • CONSORT (randomized-control) • STROBE (observation cohort) International Network for Simulation-based Pediatric Innovation, Research and Education
  • 63. How do we use Reporting Guidelines? International Network for Simulation-based Pediatric Innovation, Research and Education
  • 64. Let’s review our Research Project: Using Reporting Guidelines Small Group 3
  • 65. Objectives 1. Develop a study design using simulation as the subject of research 2. Develop a study design using simulation as an investigative methodology 3. Use Reporting Guidelines to improve study methodology International Network for Simulation-based Pediatric Innovation, Research and Education
  • 66. What changes will you be making? International Network for Simulation-based Pediatric Innovation, Research and Education
  • 67. What changes will you be making? International Network for Simulation-based Pediatric Innovation, Research and Education
  • 68. International Network for Simulation-based Pediatric Innovation, Research and Education Questions?
  • 69. www.inspireSim.com International Network for Simulation-based Pediatric Innovation, Research and Education