introduction to patient safety research

Introduction to Patient Safety Introduction to Patient Safety ResearchResearch

Introduction to Patient Safety Introduction to Patient Safety ResearchResearch

Presentation 7 - Understanding Causes: Ethnographic StudyPresentation 7 - Understanding Causes: Ethnographic Study

Presentation 7 - Understanding Causes: Ethnographic Study

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2: Table of Contents IntroductionIntroduction

Overview Study Details Patient Safety Research Te

am BackgroundBackground

Opening Points Study Rationale Setting Up a Research Tea

m MethodsMethods

Study Design and Objectives

Study Setting and Population

Data Collection Data Analysis and Interpret

ation ResultsResults

Patient Demographics Key Findings Categories of Adverse Even

ts

ConclusionConclusion Main Points Study Impact Practical Considerations

Author ReflectionsAuthor Reflections Lessons and Advice Selecting Design Overcoming Barriers Ideas for Future Research

ReferencesReferences Additional References



3: Overview ObjectiveObjective

To enhance understanding of the incidence and scope of To enhance understanding of the incidence and scope of adverse events as a basis for preventing them.adverse events as a basis for preventing them.

MethodsMethods A prospective, observational design analyzing discussion of A prospective, observational design analyzing discussion of

adverse events during care of all patients admitted to 3 units adverse events during care of all patients admitted to 3 units of a large teaching hospital.of a large teaching hospital.

Ethnographers attended regularly scheduled meetings of Ethnographers attended regularly scheduled meetings of health care providers and recorded and classified all adverse health care providers and recorded and classified all adverse events discussed. events discussed.

ResultsResults Of the 1047 patients studied, 185 (17.7%) had at least one Of the 1047 patients studied, 185 (17.7%) had at least one

serious adverse event (linked to the seriousness of the serious adverse event (linked to the seriousness of the patient's underlying illness). patient's underlying illness).

Patients with long stays in hospital had more adverse events; Patients with long stays in hospital had more adverse events; likelihood of an adverse event increased about 6% for each likelihood of an adverse event increased about 6% for each day of hospital stay.day of hospital stay.

ConclusionConclusion There is a wide range of potential causes of adverse events and There is a wide range of potential causes of adverse events and

particular attention must be paid to errors with interactive or particular attention must be paid to errors with interactive or administrative causes.administrative causes.

Health-care providers' own discussions of adverse events can Health-care providers' own discussions of adverse events can be a good source of data for proactive error prevention.be a good source of data for proactive error prevention.



4: Introduction: Study Details Full ReferenceFull Reference

Andrews LB, Stocking C, Krizek T, et al. An alternative Andrews LB, Stocking C, Krizek T, et al. An alternative strategy for studying adverse events in medical care. strategy for studying adverse events in medical care. Lancet. 1997;349:309-313Lancet. 1997;349:309-313

Link to Abstract (HTML) Link to Full Text Link to Full Text (PDF) (PDF)



5: Introduction: Patient Safety Research Team

Lead researcher - Lori B. Andrews, Lead researcher - Lori B. Andrews, JDJD Director and Law Professor, Institute Director and Law Professor, Institute

for Science, Law & Technology for Science, Law & Technology Chicago-Kent College of Law in Chicago-Kent College of Law in

Chicago, USAChicago, USA Field of expertise: law and policyField of expertise: law and policy

Other team members:Other team members: Carol Stocking, PhD Carol Stocking, PhD Thomas Krizek, MDThomas Krizek, MD Lawrence Gottlieb, MD Lawrence Gottlieb, MD Claudette Krizek, JD Claudette Krizek, JD Thomas Vargish Thomas Vargish Mark Siegler, MDMark Siegler, MD



6: Background: Opening Points True incidence of adverse events in medical settings True incidence of adverse events in medical settings

not knownnot known Various studies often report different rates of adverse Various studies often report different rates of adverse

events depending on their chosen methodology and events depending on their chosen methodology and data sourcedata source

Retrospective study of medical records is often the most Retrospective study of medical records is often the most commonly used study methodcommonly used study method

Many potential data sources to record and study the Many potential data sources to record and study the incidence of adverse events in hospital settingsincidence of adverse events in hospital settings Medical records review one of the most commonly used Medical records review one of the most commonly used

sourcessources However, records often incomplete, sparking an interest However, records often incomplete, sparking an interest

in approaching the study of adverse events with in approaching the study of adverse events with different methodology different methodology



7: Background: Study Rationale

Idea of study was to enhance understanding of the Idea of study was to enhance understanding of the incidence of adverse events as a basis for preventing incidence of adverse events as a basis for preventing themthem Data on frequency of adverse events related to Data on frequency of adverse events related to

inappropriate care in hospitals often comes from inappropriate care in hospitals often comes from medical recordsmedical records

However, chart analyses alone may be inadequate to However, chart analyses alone may be inadequate to determine the frequency of adverse eventsdetermine the frequency of adverse events Doctors alerted research team to high level of errors in Doctors alerted research team to high level of errors in

hospitals and described many errors not recorded in hospitals and described many errors not recorded in patients’ recordspatients’ records



8: Background: Setting Up a Research Team

Selecting collaboratorsSelecting collaborators Effectiveness of study relied on the outside observation Effectiveness of study relied on the outside observation

of health-care providersof health-care providers Ethnographers trained in qualitative observational Ethnographers trained in qualitative observational

research chosen to attend regularly scheduled meetings research chosen to attend regularly scheduled meetings and rounds to collect data on adverse events in medical and rounds to collect data on adverse events in medical carecare

Data collected analyzed by members of legal, medicine Data collected analyzed by members of legal, medicine and surgical departments at a major American research and surgical departments at a major American research universityuniversity

FundingFunding Obtained from Obtained from a medical malpractice study fund at the a medical malpractice study fund at the

Robert Wood Johnson FoundationRobert Wood Johnson Foundation



9: Methods: Study Design and Objectives

DesignDesign: prospective, observational ethnographic : prospective, observational ethnographic studystudy Ethnographers recorded adverse events incidentally Ethnographers recorded adverse events incidentally

mentioned at regularly scheduled meetings and mentioned at regularly scheduled meetings and developed a classification scheme to code the data developed a classification scheme to code the data

ObjectivesObjectives:: To undertake a study of potential adverse events in To undertake a study of potential adverse events in

hospitalized patients and assess the incidence, cause hospitalized patients and assess the incidence, cause and response to errorand response to error

To develop a deeper understanding of adverse events To develop a deeper understanding of adverse events than what may be available in after-the-fact analysis of than what may be available in after-the-fact analysis of medical records and prospective studies examining medical records and prospective studies examining particular proceduresparticular procedures



10: Methods: Study Population and Setting

SettingSetting: 3 units at a large, tertiary care, urban : 3 units at a large, tertiary care, urban teaching hospital in the USteaching hospital in the US During the study there were 1,047 patients in the three During the study there were 1,047 patients in the three

unitsunits One-third of the patients admitted more then once for a One-third of the patients admitted more then once for a

total of 1,716 admissionstotal of 1,716 admissions PopulationPopulation: attending surgeons and physicians, : attending surgeons and physicians,

fellows, residents, interns, nurses, and other health-fellows, residents, interns, nurses, and other health-care practitioners on ten surgical servicescare practitioners on ten surgical services



11: Methods: Data Collection

Four ethnographers trained in qualitative Four ethnographers trained in qualitative observational research chronicled discussion of observational research chronicled discussion of adverse events at regular meetingsadverse events at regular meetings Each was given a month of additional training to enable Each was given a month of additional training to enable

them to carry out field work in a medical settingthem to carry out field work in a medical setting Recorded information about all adverse events inRecorded information about all adverse events in

patient care mentioned in discussions at these meetingspatient care mentioned in discussions at these meetings Did not ask questions orDid not ask questions or make clinical judgmentsmake clinical judgments

Over a 9-month period ethnographers Over a 9-month period ethnographers observed:observed: Attending physician roundsAttending physician rounds Residents’ work roundsResidents’ work rounds Nursing shift changesNursing shift changes Case conferencesCase conferences Additional scheduled meetings in three study unitsAdditional scheduled meetings in three study units Departmental and section meetingsDepartmental and section meetings



12: Methods: Data Analysis and Interpretation

After data had been collected for two months, an After data had been collected for two months, an event classification scheme was developedevent classification scheme was developed 368 specific categories of incidents met the study 368 specific categories of incidents met the study

definitions of adverse events and were grouped into definitions of adverse events and were grouped into nine large areas: nine large areas:

• Diagnosis, surgery, anaesthesia, treatment, nutrition Diagnosis, surgery, anaesthesia, treatment, nutrition problems, drugs, monitoring and daily care, complications problems, drugs, monitoring and daily care, complications and otherand other

Observers double coded sets of data forms regularly at Observers double coded sets of data forms regularly at first, then intermittently, to ensure consistency in first, then intermittently, to ensure consistency in classifying events and other informationclassifying events and other information



13: Results: Key findings

Patient demographicsPatient demographics Patients were evenly distributed by sex and race Patients were evenly distributed by sex and race Source of payment reflected national distributionSource of payment reflected national distribution

17.7% (185) patients experienced serious events that 17.7% (185) patients experienced serious events that led to longer hospital stays and increased costs to led to longer hospital stays and increased costs to the patientsthe patients 37.8% of adverse events caused by an individual37.8% of adverse events caused by an individual 15.6% had interactive causes15.6% had interactive causes 9.8% due to administrative decisions 9.8% due to administrative decisions The highest proportion (29.3%) of adverse events The highest proportion (29.3%) of adverse events

occurred during post-operative monitoring and occurred during post-operative monitoring and care vs. during surgery itselfcare vs. during surgery itself

Only 1.2% (13) of patients experiencing adverse Only 1.2% (13) of patients experiencing adverse events made claims for compensationevents made claims for compensation



14: Results: Key Findings (2)

Occurrence of initial adverse event linked to the Occurrence of initial adverse event linked to the seriousness of the patient’s underlying illnessseriousness of the patient’s underlying illness Patients with long hospital stays had more adverse than Patients with long hospital stays had more adverse than

those with short staysthose with short stays Likelihood of experiencing an adverse event increased Likelihood of experiencing an adverse event increased

about 6% for each day of hospital stayabout 6% for each day of hospital stay Occurrence of adverse events was broadly Occurrence of adverse events was broadly

unaffected by differences in ethnicity, gender, unaffected by differences in ethnicity, gender, payor class and agepayor class and age



15: Conclusion: Main Points

There are a wide range of potential causes of There are a wide range of potential causes of adverse events that should be consideredadverse events that should be considered Careful attention must be paid to errors with interactive Careful attention must be paid to errors with interactive

or administrative causesor administrative causes Healthcare providers’ own discussions of adverse Healthcare providers’ own discussions of adverse

events can be a good source of data for proactive events can be a good source of data for proactive error preventionerror prevention



16: Conclusion: Study Impact

Academic impactAcademic impact Research published in top medical and law journals and Research published in top medical and law journals and

in health administration publicationsin health administration publications Study featured during speeches at legal and medical Study featured during speeches at legal and medical

meetings and taught in law schools across the countrymeetings and taught in law schools across the country Policy impact Policy impact

Research used by the US National Academy of Sciences Research used by the US National Academy of Sciences in proposing policyin proposing policy

Practice impactPractice impact Study subject of presentations at numerous national Study subject of presentations at numerous national

medical meetings and many doctors aware of this studymedical meetings and many doctors aware of this study



17: Conclusion: Practical Considerations

Study duration: 27 monthsStudy duration: 27 months Study design: 9 monthsStudy design: 9 months Data collection: 9 monthsData collection: 9 months Analysis: 9 monthsAnalysis: 9 months

CostCost Over $1 million USDOver $1 million USD

Required resourcesRequired resources Team of four ethnographers and three people Team of four ethnographers and three people

performing statistical analyses using computers and performing statistical analyses using computers and statistical software.statistical software.

Access to hospital information systems, patient charts, Access to hospital information systems, patient charts, incident report forms, potential claim files, claim files, incident report forms, potential claim files, claim files, complaint letters from patients, and patient request complaint letters from patients, and patient request formsforms

Ethical approvalEthical approval Took 3 months to obtainTook 3 months to obtain



18: Author Reflections: Lessons and Advice

If one thing could be done differently in the study… If one thing could be done differently in the study… "We would fund greater distribution of the results and "We would fund greater distribution of the results and

fund a follow-up study on how to use them to improve fund a follow-up study on how to use them to improve care."care."

Advice for researchersAdvice for researchers "Researchers should work closely in the development of "Researchers should work closely in the development of

health care facilities to assure that research on health care facilities to assure that research on incidence of errors is considered from the beginning."incidence of errors is considered from the beginning."

Study is easily adaptable to various settingsStudy is easily adaptable to various settings E.g. such a study could be undertaken by one E.g. such a study could be undertaken by one

observer trained in participant observation with a observer trained in participant observation with a computer and statistics programcomputer and statistics program



19: Author Reflections: Selecting Design

Alternative approachesAlternative approaches Observers could have been chosen from a field other Observers could have been chosen from a field other

than ethnographythan ethnography Study of medical records could also have been Study of medical records could also have been

undertaken to record the occurrence of adverse eventsundertaken to record the occurrence of adverse events• However, this method underreports the frequency of errors However, this method underreports the frequency of errors

in hospitalsin hospitals

Particular method chosen because of research team’s Particular method chosen because of research team’s concern about underreportingconcern about underreporting Research team judged the chosen design to give Research team judged the chosen design to give

stronger ability to study response errors and other stronger ability to study response errors and other variablesvariables



20: Author Reflections: Overcoming Barriers

ChallengeChallenge An initial barrier was the determination of who could An initial barrier was the determination of who could

say when an adverse event occurredsay when an adverse event occurred• Medical resident, ethnographer, etc?Medical resident, ethnographer, etc?• Pros and cons to each type of observerPros and cons to each type of observer

SolutionSolution Barrier was overcome by using ethnographers to record Barrier was overcome by using ethnographers to record

events as adverse events when the health care events as adverse events when the health care providers themselves called them adverse eventsproviders themselves called them adverse events



21: Author Reflections: Ideas for Future Research

Recommendations for future research in developing Recommendations for future research in developing countriescountries "If the country is moving toward computerized medical "If the country is moving toward computerized medical

records, research on how erroneous information can records, research on how erroneous information can enter a patient’s record, be difficult to remove, and enter a patient’s record, be difficult to remove, and compromise patient care."compromise patient care."



22: Additional References

““Studying Medical Error Studying Medical Error in Situin Situ: Implications for : Implications for Malpractice Law and Policy,” 54 Malpractice Law and Policy,” 54 DePaul Law DePaul Law ReviewReview 357 (2005). 357 (2005).

introduction to patient safety research

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