Research in the Patient Safety Strategy. David Bates. IV Internacional Conference on Patient Safety (Madrid, Ministry of Health and Consumer Affairs, 2008)
1. Patient Safety Research
Madrid, 2008
David W. Bates, MD, MSc
External Program Lead, Research
World Alliance for Patient Safety
2. Overview
™Why is research needed?
™Review of evidence
™Directions of research program of World
Alliance
Prior work
Future plans
™Conclusions
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3. Why Research--Epidemiology?
™To get local data
Will be variation by site, country
™Allows estimation of return on investment
™Makes possible rational prioritization of
solutions
Many more solutions than any country can afford
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4. Why Do Research—Solutions?
™Many solutions may not work at all
Or in certain settings
Or when implemented in specific ways
Cultural issues
™Again, resources are scarce and need to
prioritize
Far too many options even for safety
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5. To Err is Human
™ Errors are common
™ Errors are costly
™ Systems cause errors
™ Errors can be prevented
and safety can be
improved
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6. Global Picture of Patient Safety
™ Clear from many studies that is an important problem
in every country evaluated
Adverse event rate in hospitalized patients about 10% in most
developed countries
Know much less about the developing world
™ Know much more about safety in the hospital than
safety outside it
Yet limited data available suggest that the magnitude of the
problem is about as big outside hospitals
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7. Background Report: Objectives
Led by Ashish Jha, MD
™Create framework for approaching topics
™Identify major topics in patient safety
™Describe the epidemiology, severity and
potential for intervention
™Identify gaps in knowledge to inform priority
setting
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8. The Report
™ Framework
ƒ Structural factors that affect safety
• e.g. safety culture
ƒ Processes of care that impact safety
• e.g. safe injection practices
ƒ Outcomes of unsafe care
• e.g. healthcare-associated infections
™ Alternatives / over-lays:
ƒ Clinical setting (ambulatory, hospital care, etc.)
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9. The Report
™Goal to identify major issues in patient safety
ƒ 23 major topics identified
ƒ Report available on World Alliance website
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10. Structural Topics
Organizational determinants and latent failures
Accreditation and regulation to advance patient safety
Safety culture
Inadequate training and education; workforce issues
Stress and fatigue
Production pressures
Lack of appropriate knowledge and availability of knowledge, transfer of knowledge
Adequate measures of patient safety
Devices, procedures without human factors engineering
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11. Process Topics
Errors in care through misdiagnosis
Errors in care through poor test follow-Up
Errors in care: counterfeit / substandard drugs
Errors in care: unsafe injection practices
Bringing patients’ voices into patient safety
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12. Outcomes Topics
Adverse events and injuries due to medical devices
Adverse events due to medications
Adverse Events due to surgical errors
Adverse events due to health-care associated Infections
Adverse events due to unsafe blood products
Adverse events due to falls in the hospital
Injury due to pressure sores and decubitus ulcers
Patient safety concerns among the elderly
Patients safety among pregnant women and newborns
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13. Major Findings
™Structural factors:
ƒ Nearly all the data from developed nations
ƒ Little data about features of organizational structures
that optimize safety
ƒ Data from developed nations have begun to quantify
• Impact of stress, fatigue, and lack of knowledge
on safety
• Production pressures
• The role of human factors engineering
ƒ Unclear how these translate to developing and
transitional countries
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14. Implications and Recommendations
™Likely substantial burden from unsafe care
ƒ Especially in developing and transitional nations
ƒ Need better data to describe epidemiology, impact
™Structure/process/outcomes may be useful
ƒ Lack of data about underlying processes, structures
™Large gaps in knowledge about solutions
ƒ Still in infancy in developed nations
ƒ Which solutions transportable largely unknown
ƒ Strategies to reduce AE for developing and transitional nations
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15. Global Priorities
for Patient Safety Research
™Developed a set of global priorities for patient
safety research
™Stratified by level of development
Developing
Transitional
Developed
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16. Priority Setting Working Group
™ Produced an agenda
of research priorities,
stratified by level of
development
™ Led by David Bates,
with support of Ashish
Jha
™ Through Lit review,
Delphi technique &
extensive
consultation
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17. Priorities Process
™Followed a modified Delphi approach
Three rounds, each time with discussion
™Also developed a short description of a
process an individual country can follow
™For each priority we identified key
research questions (intended as
examples, not necessarily the most
important)
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18. Developed Countries
1. Lack of communication and coordination (including hand-offs)
2. Latent organizational failures
3. Poor safety culture and blame-oriented processes
4. Cost-effectiveness of risk-reducing strategies
5. Developing better safety indicators (including a global safety
indicator)
6. Procedures that lack human factors consideration built into design
7. Health information technology/information systems
8. Patients' role in shaping the research agenda
9. Devices that lack human factors consideration built into design
10. Adverse drug events/medication errors
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19. Transitional Countries
1. Development & testing of locally effective and affordable solutions
2. Cost-effectiveness of risk-reducing strategies
3. Lack of appropriate knowledge, transfer of knowledge
4. Inadequate competences, training and skills
5. Lack of communication and coordination (including hand-offs)
6. Poor safety culture and blame-oriented processes
7. Health care associated infections
8. Extent and nature of the problem of patient safety
9. Latent organizational failures
10. Developing better safety indicators (including a global safety
indicator)
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20. Developing Countries
1. Development & testing of locally effective and affordable solutions
2. Cost-effectiveness of risk-reducing strategies
3. Counterfeit and Substandard Drugs (including traditional
medicines)
4. Inadequate competences, training and skills
5. Maternal and Newborn Care
6. Health care associated infections
7. Study of the extent and nature of the problem of patient safety
8. Lack of appropriate knowledge and transfer of knowledge
9. Unsafe injection practices
10. Unsafe blood practices
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21. Advancing Methods & Tools Working Group
™ To assess strengths &
weaknesses of methods for
research on patient safety,
™ To inform on best methods
& tools for specific research
questions and data settings
™ Through lit review, testing
of new methods and expert
consultation
™ Led by Ross Baker
(Toronto U) and Bill
Runciman (Australia)
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22. Advancing Methods & Tools:
Accomplishments
™ Main working directions were identified
™ Draft papers for each of the theoretical directions
have been produced, reviewed
Acute care
Primary care
Interventions
™ Producing tools for use in developing countries
™ New effort to develop set of indicators for developing,
transitional countries
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23. Research Studies in Developing
Countries
™ To estimate the magnitude and main causes of patient
harm
To stimulate actions at local and regional level
To build on regional initiatives
™ Performed multi-country study in EMRO and in two
countries in AFRO
Ross Wilson (Australia), Philippe Michel (France), Sisse Olsen
(UK), Charles Vincent (UK)
™ Performed multi-country study project in Latin-America
(PAHO)—IBEAS study
In collaboration with Spain MOH
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24.
25.
26. Preliminary EMRO/AFRO Results
™Health care is causing permanent disability
and death in developing and transitional
countries
™Much of this harm is preventable (~75%)
™Final report to be released soon
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27. Lessons Learned So Far
™ Building a team was essential for completion of
project as well doing something with the results
™ Patient safety can galvanise attention and interest
such that it leads to huge local effort
™ Connecting the project through regional WHO
organization to Health Ministries in each country was
crucial
™ Medical record quality is improved by promulgation of
standards (Egypt & Kenya)
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28. New Initiatives
™Training program on patient safety research
™Small-grant research program
™New research studies
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29. Education for Patient Safety
Researchers
™ Considering educational opportunities at various levels: (i)
Scholar high degree level-masters & PhD; (ii) Short
courses/diplomas; (iii) in-service training
™ Building on available capacity and people, institutions,
groups, organizations by regions (linking with colleges
and academia)
™ Developing local advocates and champions
™ Action:
Situational analysis: organizational and program models, funding,
target audience, faculty, and curriculum; mapping of potential
resources, including existing collaborations
Expert working group—led by Peter Norton (Canada), Narendra
Arora (India)
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30. The Small Research Grants
Program for Patient Safety
Aims
• To stimulate research in patient
safety research in developing
and transitional countries -
providing seed funding
• To contribute to local capacity
building –targeting young or
early- to mid-career researchers
• To promote the culture of patient
safety - facilitating dissemination
of research findings.
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31. Objectives and Workplan
Workplan
Funding 20-30 small research projects in 2009 (>200
applications)
• Initial deadline September 30, 2008
• Grants of 10 000 - 25 000 per project
• For projects that can be completed in 12-18 months
• Encourage researchers from developing/transitional
countries as lead investigator
• Dissemination of research findings is compulsory
Formulation Management, Evaluation
Communication
& preparation monitoring & reporting
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32. New Research Studies
™Have commissioned new research work
focusing on program priority areas:
Modeling global burden of unsafe care
Indicators and tool development
Implementation research for maternal and neonatal
care
Methodological guide for developing countries
Meta-analysis of existing prevalence studies
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33. Conclusions
™ Safety is a problem in all nations
Need research to understand problem, learn what to do first
™ Know much less about problem in developing,
transitional countries
All nations need to begin to address research in this area
ƒ Public responds very positively
™ Developed countries: communication, latent failures,
safety culture high priority
™ Developing/transitional countries: developing/testing
locally affordable solutions
™ All countries want to provide safer care
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Patient Safety | 09 December 2008