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

The Report Goal to identify major issues in patient safety 23 major topics identified 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: 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 knowledge on safety • Production pressures • The role of human factors engineering 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 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 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 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

Research in the Patient Safety Strategy

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