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Patient Safety Research

           Madrid, 2008


     David W. Bates, MD, MSc

  External Program Lead, Research

  World Alliance for Patient Safety
Overview


™Why is research needed?
™Review of evidence
™Directions of research program of World
 Alliance

       Prior work

       Future plans


™Conclusions


2|   Research Program: WHO World Alliance for
     Patient Safety | 09 December 2008
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




3|   Research Program: WHO World Alliance for
     Patient Safety | 09 December 2008
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



4|   Research Program: WHO World Alliance for
     Patient Safety | 09 December 2008
To Err is Human


 ™ Errors are common
 ™ Errors are costly
 ™ Systems cause errors
 ™ Errors can be prevented
   and safety can be
                                                


   improved





5|   Research Program: WHO World Alliance for
     Patient Safety | 09 December 2008
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




6|   Research Program: WHO World Alliance for
     Patient Safety | 09 December 2008
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
                     





7|   Research Program: WHO World Alliance for
     Patient Safety | 09 December 2008
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.)

8|   Research Program: WHO World Alliance for
     Patient Safety | 09 December 2008
The Report


 ™Goal to identify major issues in patient safety
              ƒ 23 major topics identified
              ƒ Report available on World Alliance website




9|   Research Program: WHO World Alliance for
     Patient Safety | 09 December 2008
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


10 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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




11 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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


12 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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
13 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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


14 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
Global Priorities
 for Patient Safety Research

 ™Developed a set of global priorities for patient
  safety research
 ™Stratified by level of development
         Developing
         Transitional
         Developed




15 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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


16 |    Research Program: WHO World Alliance for
        Patient Safety | 09 December 2008
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)

17 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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


18 |    Research Program: WHO World Alliance for
        Patient Safety | 09 December 2008
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)


19 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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


20 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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)




21 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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


22 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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


23 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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




26 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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)

27 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
New Initiatives


 ™Training program on patient safety research
 ™Small-grant research program
 ™New research studies




28 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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)
29 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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.

30 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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




31 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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


32 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008
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

33 |   Research Program: WHO World Alliance for
       Patient Safety | 09 December 2008

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Research in the Patient Safety Strategy

  • 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 2| Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 3| Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 4| Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 5. To Err is Human ™ Errors are common ™ Errors are costly ™ Systems cause errors ™ Errors can be prevented and safety can be improved 5| Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 6| Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 7| Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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.) 8| Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 9. The Report ™Goal to identify major issues in patient safety ƒ 23 major topics identified ƒ Report available on World Alliance website 9| Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 10 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 11 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 12 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 13 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 14 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 15 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 16 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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) 17 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 18 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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) 19 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 20 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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) 21 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 22 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 23 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 26 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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) 27 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 28. New Initiatives ™Training program on patient safety research ™Small-grant research program ™New research studies 28 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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) 29 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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. 30 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 31 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 32 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008
  • 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 33 | Research Program: WHO World Alliance for Patient Safety | 09 December 2008