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Evaluation of
Health IT Implementation
Sep 17, 2015
Nawanan Theera-Ampornpunt, M.D., Ph.D.
Informatics Evaluation Methods Book
Friedman & Wyatt (2006)
Why Evaluate Projects?
• Promotional: To encourage more use
• Scholarly: To confirm or create scientific
knowledge
• Pragmatic: To know what works and what fails
• Ethical: To ensure appropriateness & justify its
use or its budget
• Medicolegal: To reduce liability risks
Friedman & Wyatt (2006)
Complexity of Evaluation in Informatics
Friedman & Wyatt (2006)
Medicine &
Health care
Evaluation
Methodology
Information
Systems
Marchewka JT (2006)
Project Life Cycle & SDLC
Marchewka JT (2006)
IT Project Management Deliverables
Class Exercise 1
• How would you evaluate the success
of your project to implement
Computerized Physician Order Entry
(CPOE) in your hospital?
– What defines success
– Measurement methods
• DeLone & McLean’s IS Success Model (1992;2003)
• Revised model in 2003 adds “Service Quality”
Various Ways to Measure Success
DeLone & McLean (1992; 2003)
Health IT as Healthcare Interventions
• Donabedian’s Model
Donabedian (1966), Friedman & Wyatt (2006)
Structure Processes Outcomes
Class Exercise 2
• Can you provide some examples of
measures in each aspect in the
Donabedian’s model that help evaluate
health IT project success?
A Mindset for Evaluation
• Tailor the study to the problem
• Collect data useful for making decisions
• Look for intended and unintended effects
• Study the resource while it is under development and
after it is deployed
• Study the resource in the lab and in the field
• Go beyond the developer’s point of view
• Take the environment into account
• Let the key issues emerge over time
• Be methodologically Catholic and eclectic
Friedman & Wyatt (2006)
Evaluation vs. Traditional Research
• Different goals
• Who (clients or evaluators) determines the agenda
• Evaluation actively seeks unanticipated effects as well
as anticipated ones
• Both lab and in-situ evaluations important for evaluation
• Evaluations often employ many data-collection paradigm
Friedman & Wyatt (2006)
Evaluation Approaches
• Objectivist vs. Subjectivist approaches
• Objectivist characteristics
– Information resources, users, and processes can be measured
– Rational persons should agree on important measures and
desirable outcomes
– It is possible to disprove a hypothesis, but never to fully prove
one
– Quantitative measurement is superior and more precise to
qualitative methods
– We can assess which resource is superior through comparisons
Friedman & Wyatt (2006)
Evaluation Approaches
• Objectivist vs. Subjectivist approaches
• Subjectivist characteristics
– What is observed depends fundamentally on the observer
– Context is crucial
– Different perspectives can be legitimately valid on desirable
outcomes
– Verbal description can be highly illuminating
– Evaluation is viewed as an exercise in argument, rather than
demonstration
Friedman & Wyatt (2006)
Objectivist Approaches
Objectivist
• Comparison-Based Approach
• Objectives-Based Approach (against stated goals)
• Decision-Facilitation Approach (evaluation to resolve
issues important for decision-making for further
development)
• Goal-Free Approach (purposefully blinded to intended
effects)
Friedman & Wyatt (2006)
Subjectivist Approaches
Subjectivist
• Quasi-Legal Approach (e.g. a mock trial)
• Art Criticism Approach
• Professional Review Approach (e.g. site visit by
experienced peers)
• Responsive/Illuminative Approach (derived from
ethnography)
Friedman & Wyatt (2006)
Objectivist Studies
• Measurement studies
– “Studies undertaken to develop and refine methods for making
measurements”
– E.g. development and validation of measurement methods,
tools, questionnaires
• Demonstration studies
– Studies that use measurement “methods to address questions of
direct importance in informatics”
– Descriptive studies (no independent variables)
– Comparative studies (investigator creates a contrasting set of
conditions, as in experiments & quasi-experiments)
– Correlational studies (explore hypothesized relationships among
variables that were not manipulated)
Friedman & Wyatt (2006)
Study Designs
• Experiments
– Randomized controlled trials
• Quasi-Experiments
– Non-randomized interventions
– Investigator still controls assignment of subjects to
interventions but not through randomization
• Observational Studies
– Investigator has no control over assignment of
subjects into groups
Friedman & Wyatt (2006)
Quasi-Experiments
Harris et al. (2006)
Quasi-Experiments
Harris et al. (2006)
Quasi-Experiments
Harris et al. (2006)
Quasi-Experiments
Harris et al. (2006)
Observational Studies
• Cohort studies
– Observe subjects with different exposures over time and
compare outcomes
• Case-control studies
– Compare subjects with outcome of interests (cases) and without
(controls) retrospectively to determine differences in exposure
• Cross-sectional studies
Mann (2003)
Measurements
Friedman & Wyatt (2006) Source: http://ibis.health.state.nm.us/resources/ReliabilityValidity.html
Measurement Validity & Reliability
Source: http://ibis.health.state.nm.us/resources/ReliabilityValidity.html
Measurement Validity
• Content Validity & Face Validity
• Criterion-Related Validity
– Predictive validation
– Concurrent validation
• Construct Validity
– Convergent validity
– Divergent/discriminant validity
• Not the same as internal validity &
external validity of scientific studies
Friedman & Wyatt (2006)
Measurement Reliability
• Test-retest reliability
• Interrater reliability
– E.g. Kappa, intraclass correlations
• Internal consistency reliability
– E.g. Cronbach’s alpha
Threats to Internal Validity: Biases
• Assessment bias
• Allocation and recruitment bias
• The Hawthorne Effect (the tendency for humans to
improve their performance if they know it is being
studied)
• Data collection biases
– Checklist effect
– Data completeness effect (more complete data in intervention cases
than controls)
– Feedback effect
– Carryover effect (spillover effect)
– Placebo effect
– Second-look bias
Friedman & Wyatt (2006)
Threats to Internal Validity
Harris et al. (2006)
Threats to Internal Validity: Confounding
Harris et al. (2006)
Threats to External Validity
• Study generalizability
– Sample representativeness
– Intervention (including implementation strategies)
– Context
• Developers as evaluators
Friedman & Wyatt (2006)
Making Conclusions
• Internal and external validity
• Correlation vs. causation
• Acknowledgement of study limitations
• Anticipated vs. unanticipated effects
• Lessons learned
Special Study Methods Used in Informatics
• Surveys
– Study design: Cross-sectional vs. longitudinal
– Subjects
– Sampling methods
• Census
• Random sampling (simple, stratified, cluster)
• Nonproblability sampling (purposive sampling,
quota sampling, etc.)
– Sampling frame
Surveys
• Survey Methodology
– Survey delivery methods: paper, electronic
(e-mail, web site)
– Survey administration: self-administered vs.
investigator-administered
– Survey instrument (items)
– Survey design
– Item wording
Errors in Survey Studies
• Sampling errors
• Coverage errors
• Nonresponse errors
• Measurement errors
• Processing errors
OMB (2001)
Survey Book
Dillman et al. (2014)
Special Study Methods Used in Informatics
• Time and Motion Studies
(Time-Motion Studies)
• Economic Analysis
– Cost-effectiveness analysis
– Cost-benefit analysis
– Cost-utility analysis
– Economic impact analysis
– Return on investment analysis
Special Study Methods Used in Informatics
• Qualitative Studies
– Interviews
– Focused groups
– Usability evaluations
– Content analysis
Special Study Methods Used in Informatics
• Software Testing & Evaluation
Methodology
• Testing Levels
– Unit testing
– Integration testing
– System testing
– System integration testing
http://en.wikipedia.org/wiki/Software_testing
Software Testing & Evaluation
• Software Testing Objectives
– Installation testing
– Compatibility testing
– Smoke and sanity testing
– Regression testing
– User acceptance testing
– Functional testing
– Usability testing
– Alpha & beta testing
– Software performance testing
– Security testing
http://en.wikipedia.org/wiki/Software_testing
Software Testing & Evaluation
• Approaches
– White-box testing
– Black-box testing
– Gray-box testing
http://en.wikipedia.org/wiki/Software_testing
Image source: Senoo et al. (2007)
Nonaka SECI Model
During
Implementation,
Near Go-Live &
Post Go-Live
After Action
Review (AAR) /
Postmortem
Meeting,
Project Evaluation
Before & After
Project Kick-off,
During Project
Planning
During
Implementation,
Near Go-Live
Training
Project Evaluation as Part of Project’s KM
“Half the money I spend on
advertising is wasted; the trouble is
I don't know which half.”
-- John Wanamaker
http://www.quotationspage.com/quote/1992.html, http://en.wikipedia.org/wiki/John_Wanamaker
References
• DeLone WH, McLean ER. Information systems success: the quest for the
dependent variable. Inform Syst Res. 1992 Mar;3(1):60-95.
• DeLone WH, McLean ER. The DeLone and McLean model of information
systems success: a ten-year update. J Manage Inform Syst. 2003
Spring;19(4):9-30.
• Donabedian A. Evaluating the quality of medical care. Millbank Mem Q.
1966;44:166-206.
• Friedman CP, Wyatt JC. Evaluation methods in biomedical informatics. 2nd
ed. New York (NY): Springer; 2006. 386 p.
• Harris AD, McGregor JC, Perencevich EN, Furuno JP, Zhu J, Peterson DE,
Finkelstein J. The use and interpretation of quasi-experimental studies in
medical informatics. J Am Med Inform Assoc. 2006 Jan-Feb;13(1):16-23.
References
• Mann CJ. Observational research methods. Research design II: cohort,
corss sectional, and case-control studies. Emerg Med J. 2003;20:54-60.
• Office of Management and Budget, Office of Information and Regulatory
Affairs, Statistical Policy Office. Statistical policy working paper 31:
Measuring and reporting sources of error in surveys. 2001 Jul.

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Evaluation of Health IT Implementation

  • 1. Evaluation of Health IT Implementation Sep 17, 2015 Nawanan Theera-Ampornpunt, M.D., Ph.D.
  • 2. Informatics Evaluation Methods Book Friedman & Wyatt (2006)
  • 3. Why Evaluate Projects? • Promotional: To encourage more use • Scholarly: To confirm or create scientific knowledge • Pragmatic: To know what works and what fails • Ethical: To ensure appropriateness & justify its use or its budget • Medicolegal: To reduce liability risks Friedman & Wyatt (2006)
  • 4. Complexity of Evaluation in Informatics Friedman & Wyatt (2006) Medicine & Health care Evaluation Methodology Information Systems
  • 5. Marchewka JT (2006) Project Life Cycle & SDLC
  • 6. Marchewka JT (2006) IT Project Management Deliverables
  • 7. Class Exercise 1 • How would you evaluate the success of your project to implement Computerized Physician Order Entry (CPOE) in your hospital? – What defines success – Measurement methods
  • 8. • DeLone & McLean’s IS Success Model (1992;2003) • Revised model in 2003 adds “Service Quality” Various Ways to Measure Success DeLone & McLean (1992; 2003)
  • 9. Health IT as Healthcare Interventions • Donabedian’s Model Donabedian (1966), Friedman & Wyatt (2006) Structure Processes Outcomes
  • 10. Class Exercise 2 • Can you provide some examples of measures in each aspect in the Donabedian’s model that help evaluate health IT project success?
  • 11. A Mindset for Evaluation • Tailor the study to the problem • Collect data useful for making decisions • Look for intended and unintended effects • Study the resource while it is under development and after it is deployed • Study the resource in the lab and in the field • Go beyond the developer’s point of view • Take the environment into account • Let the key issues emerge over time • Be methodologically Catholic and eclectic Friedman & Wyatt (2006)
  • 12. Evaluation vs. Traditional Research • Different goals • Who (clients or evaluators) determines the agenda • Evaluation actively seeks unanticipated effects as well as anticipated ones • Both lab and in-situ evaluations important for evaluation • Evaluations often employ many data-collection paradigm Friedman & Wyatt (2006)
  • 13. Evaluation Approaches • Objectivist vs. Subjectivist approaches • Objectivist characteristics – Information resources, users, and processes can be measured – Rational persons should agree on important measures and desirable outcomes – It is possible to disprove a hypothesis, but never to fully prove one – Quantitative measurement is superior and more precise to qualitative methods – We can assess which resource is superior through comparisons Friedman & Wyatt (2006)
  • 14. Evaluation Approaches • Objectivist vs. Subjectivist approaches • Subjectivist characteristics – What is observed depends fundamentally on the observer – Context is crucial – Different perspectives can be legitimately valid on desirable outcomes – Verbal description can be highly illuminating – Evaluation is viewed as an exercise in argument, rather than demonstration Friedman & Wyatt (2006)
  • 15. Objectivist Approaches Objectivist • Comparison-Based Approach • Objectives-Based Approach (against stated goals) • Decision-Facilitation Approach (evaluation to resolve issues important for decision-making for further development) • Goal-Free Approach (purposefully blinded to intended effects) Friedman & Wyatt (2006)
  • 16. Subjectivist Approaches Subjectivist • Quasi-Legal Approach (e.g. a mock trial) • Art Criticism Approach • Professional Review Approach (e.g. site visit by experienced peers) • Responsive/Illuminative Approach (derived from ethnography) Friedman & Wyatt (2006)
  • 17. Objectivist Studies • Measurement studies – “Studies undertaken to develop and refine methods for making measurements” – E.g. development and validation of measurement methods, tools, questionnaires • Demonstration studies – Studies that use measurement “methods to address questions of direct importance in informatics” – Descriptive studies (no independent variables) – Comparative studies (investigator creates a contrasting set of conditions, as in experiments & quasi-experiments) – Correlational studies (explore hypothesized relationships among variables that were not manipulated) Friedman & Wyatt (2006)
  • 18. Study Designs • Experiments – Randomized controlled trials • Quasi-Experiments – Non-randomized interventions – Investigator still controls assignment of subjects to interventions but not through randomization • Observational Studies – Investigator has no control over assignment of subjects into groups Friedman & Wyatt (2006)
  • 23. Observational Studies • Cohort studies – Observe subjects with different exposures over time and compare outcomes • Case-control studies – Compare subjects with outcome of interests (cases) and without (controls) retrospectively to determine differences in exposure • Cross-sectional studies Mann (2003)
  • 24. Measurements Friedman & Wyatt (2006) Source: http://ibis.health.state.nm.us/resources/ReliabilityValidity.html
  • 25. Measurement Validity & Reliability Source: http://ibis.health.state.nm.us/resources/ReliabilityValidity.html
  • 26. Measurement Validity • Content Validity & Face Validity • Criterion-Related Validity – Predictive validation – Concurrent validation • Construct Validity – Convergent validity – Divergent/discriminant validity • Not the same as internal validity & external validity of scientific studies Friedman & Wyatt (2006)
  • 27. Measurement Reliability • Test-retest reliability • Interrater reliability – E.g. Kappa, intraclass correlations • Internal consistency reliability – E.g. Cronbach’s alpha
  • 28. Threats to Internal Validity: Biases • Assessment bias • Allocation and recruitment bias • The Hawthorne Effect (the tendency for humans to improve their performance if they know it is being studied) • Data collection biases – Checklist effect – Data completeness effect (more complete data in intervention cases than controls) – Feedback effect – Carryover effect (spillover effect) – Placebo effect – Second-look bias Friedman & Wyatt (2006)
  • 29. Threats to Internal Validity Harris et al. (2006)
  • 30. Threats to Internal Validity: Confounding Harris et al. (2006)
  • 31. Threats to External Validity • Study generalizability – Sample representativeness – Intervention (including implementation strategies) – Context • Developers as evaluators Friedman & Wyatt (2006)
  • 32. Making Conclusions • Internal and external validity • Correlation vs. causation • Acknowledgement of study limitations • Anticipated vs. unanticipated effects • Lessons learned
  • 33. Special Study Methods Used in Informatics • Surveys – Study design: Cross-sectional vs. longitudinal – Subjects – Sampling methods • Census • Random sampling (simple, stratified, cluster) • Nonproblability sampling (purposive sampling, quota sampling, etc.) – Sampling frame
  • 34. Surveys • Survey Methodology – Survey delivery methods: paper, electronic (e-mail, web site) – Survey administration: self-administered vs. investigator-administered – Survey instrument (items) – Survey design – Item wording
  • 35. Errors in Survey Studies • Sampling errors • Coverage errors • Nonresponse errors • Measurement errors • Processing errors OMB (2001)
  • 37. Special Study Methods Used in Informatics • Time and Motion Studies (Time-Motion Studies) • Economic Analysis – Cost-effectiveness analysis – Cost-benefit analysis – Cost-utility analysis – Economic impact analysis – Return on investment analysis
  • 38. Special Study Methods Used in Informatics • Qualitative Studies – Interviews – Focused groups – Usability evaluations – Content analysis
  • 39. Special Study Methods Used in Informatics • Software Testing & Evaluation Methodology • Testing Levels – Unit testing – Integration testing – System testing – System integration testing http://en.wikipedia.org/wiki/Software_testing
  • 40. Software Testing & Evaluation • Software Testing Objectives – Installation testing – Compatibility testing – Smoke and sanity testing – Regression testing – User acceptance testing – Functional testing – Usability testing – Alpha & beta testing – Software performance testing – Security testing http://en.wikipedia.org/wiki/Software_testing
  • 41. Software Testing & Evaluation • Approaches – White-box testing – Black-box testing – Gray-box testing http://en.wikipedia.org/wiki/Software_testing
  • 42. Image source: Senoo et al. (2007) Nonaka SECI Model During Implementation, Near Go-Live & Post Go-Live After Action Review (AAR) / Postmortem Meeting, Project Evaluation Before & After Project Kick-off, During Project Planning During Implementation, Near Go-Live Training Project Evaluation as Part of Project’s KM
  • 43. “Half the money I spend on advertising is wasted; the trouble is I don't know which half.” -- John Wanamaker http://www.quotationspage.com/quote/1992.html, http://en.wikipedia.org/wiki/John_Wanamaker
  • 44. References • DeLone WH, McLean ER. Information systems success: the quest for the dependent variable. Inform Syst Res. 1992 Mar;3(1):60-95. • DeLone WH, McLean ER. The DeLone and McLean model of information systems success: a ten-year update. J Manage Inform Syst. 2003 Spring;19(4):9-30. • Donabedian A. Evaluating the quality of medical care. Millbank Mem Q. 1966;44:166-206. • Friedman CP, Wyatt JC. Evaluation methods in biomedical informatics. 2nd ed. New York (NY): Springer; 2006. 386 p. • Harris AD, McGregor JC, Perencevich EN, Furuno JP, Zhu J, Peterson DE, Finkelstein J. The use and interpretation of quasi-experimental studies in medical informatics. J Am Med Inform Assoc. 2006 Jan-Feb;13(1):16-23.
  • 45. References • Mann CJ. Observational research methods. Research design II: cohort, corss sectional, and case-control studies. Emerg Med J. 2003;20:54-60. • Office of Management and Budget, Office of Information and Regulatory Affairs, Statistical Policy Office. Statistical policy working paper 31: Measuring and reporting sources of error in surveys. 2001 Jul.