Research in the Patient Safety Strategy

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

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

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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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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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To Err is Human

� Errors are common

� Errors are costly

� Systems cause errors

� Errors can be prevented and safety can be

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

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

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The Report

� Framework � Structural factors that affect safety

• e.g. safety culture

� Processes of care that impact safety

• e.g. safe injection practices

� Outcomes of unsafe care

• e.g. healthcare-associated infections

� Alternatives / over-lays: � Clinical setting (ambulatory, hospital care, etc.)


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The Report

�Goal to identify major issues in patient safety �23 major topics identified

�Report available on World Alliance website


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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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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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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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Major Findings

�Structural factors: �Nearly all the data from developed nations �Little data about features of organizational structures

that optimize safety �Data from developed nations have begun to quantify

• Impact of stress, fatigue, and lack of knowledgeon safety

• Production pressures• The role of human factors engineering

�Unclear how these translate to developing andtransitional countries


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Implications and Recommendations

�Likely substantial burden from unsafe care � Especially in developing and transitional nations

� Need better data to describe epidemiology, impact

�Structure/process/outcomes may be useful � Lack of data about underlying processes, structures

�Large gaps in knowledge about solutions

� Still in infancy in developed nations

� Which solutions transportable largely unknown

� Strategies to reduce AE for developing and transitional nations


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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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Priority Setting Working Group � Produced an agenda

of research priorities,stratified by level ofdevelopment

� Led by David Bates,with support of AshishJha

� Through Lit review,Delphi technique &extensive consultation


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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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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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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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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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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, testingof new methods and expertconsultation

� Led by Ross Baker(Toronto U) and BillRunciman (Australia)


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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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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 twocountries 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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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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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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New Initiatives

�Training program on patient safety research

�Small-grant research program

�New research studies


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Education for Patient Safety Researchers � Considering educational opportunities at various levels: (i)

Scholar high degree level-masters & PhD; (ii) Shortcourses/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), NarendraArora (India)


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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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Objectives andObjectives and Workplan Workplan

Funding 20-30 small research projects in 2009 (>200applications)

• 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/transitionalcountries as lead investigator

• Dissemination of research findings is compulsory

Formulation & preparation Communication Management,

monitoring Evaluation & reporting


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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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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 � Public responds very positively

� Developed countries: communication, latent failures,safety culture high priority

� Developing/transitional countries: developing/testinglocally affordable solutions

� All countries want to provide safer care


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Research in the Patient Safety Strategy

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