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Research article

The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada

G. Ross Baker, Peter G. Norton, Virginia Flintoft, Régis Blais, Adalsteinn Brown, Jafna Cox, Ed Etchells, William A. Ghali, Philip Hébert, Sumit R. Majumdar, Maeve O'Beirne, Luz Palacios-Derflingher, Robert J. Reid, Sam Sheps and Robyn Tamblyn
CMAJ May 25, 2004 170 (11) 1678-1686; DOI: https://doi.org/10.1503/cmaj.1040498
G. Ross Baker
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Peter G. Norton
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Virginia Flintoft
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Régis Blais
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Adalsteinn Brown
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Jafna Cox
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Ed Etchells
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William A. Ghali
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Philip Hébert
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Sumit R. Majumdar
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Maeve O'Beirne
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Luz Palacios-Derflingher
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Robert J. Reid
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Sam Sheps
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Robyn Tamblyn
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  • The Canadian Adverse Events Study.1
    Maurice McGregor
    Posted on: 24 June 2004
  • Adverse Events in Canadian Hospitals: The Tip of the Iceberg
    Peter J. Zed & Richard S. Slavik
    Posted on: 01 June 2004
  • The Canadian Adverse Events Study
    J A Chris Delaney
    Posted on: 31 May 2004
  • Prevention of hospital adverse events
    Ediriweera B.R., Desapriya
    Posted on: 26 May 2004
  • Posted on: (24 June 2004)
    The Canadian Adverse Events Study.1
    • Maurice McGregor

    The results of this study, particularly those that are (mis)reported in the media will cause anxiety to patients contemplating hospitalization. In order to limit unnecessary anxiety, careful attention should be given to details that may be missed by the rapid reader.

    Adverse events (AEs) occurred with 7.5% of admissions. One should note that of these, nearly one third occurred up to 12 months preceding the index...

    Show More

    The results of this study, particularly those that are (mis)reported in the media will cause anxiety to patients contemplating hospitalization. In order to limit unnecessary anxiety, careful attention should be given to details that may be missed by the rapid reader.

    Adverse events (AEs) occurred with 7.5% of admissions. One should note that of these, nearly one third occurred up to 12 months preceding the index admission. The risk of experiencing an AE associated with actually being hospitalized would, with these events excluded, be closer to 5.2%.

    AEs are defined as unintended injuries or complications that are caused by healthcare management, that lead to death, disability, or prolonged hospital stay. Their frequency was estimated by asking a single chart reviewer to judge the likelihood that an event (previously identified) had been caused by health care management, on a six-point scale of probability. The final number was based not on the events in which management causation was considered to be “virtually certain”, or even on those in which the evidence of causation was considered to be “moderate to strong”, but on all events in which causation by management was judged to be more than 50% probable. It must therefore, have included events in which the chart reviewer was in considerable doubt.

    It is unfortunate that the reader is unable to distinguish between serious and more trivial events, because death, disability (temporary and permanent) and prolongation of hospitalization, were all pooled together as a single outcome, a strategy which increases statistical significance, but at the expense of clinical meaning. It is comforting to learn that for “most of the patients” who experienced an adverse event “their AEs contributed to longer stays in hospital or temporary disability”. We do not know whether the extensions of hospital stay were a matter of hours, days, or months.

    However, to most healthcare professionals who are already well aware that all procedures are associated with some risk, the outcome of greatest interest in this study is the rate of preventable adverse events, which was estimated to be 2.8%. (Again, if one excludes the third of events that took place before hospitalization, the rate actually associated with hospital admission would be of the order of 1.9%).

    To decide on the basis of retrospective chart review, first which events were attributable to management, and next which were preventable, must often have been extremely difficult. It is not surprising that in the 10% of charts that were read by two physicians, there was only “moderate agreement in assessing injury, preventability and the contribution of healthcare management to AEs” (Kappa scores 0.47, 0.69, 0.45, respectively).

    To help readers make up their own minds the authors commendably provide a brief description of the clinical details of adverse events on the Web. However, perusal of these raises more doubts about classification. Thirty-nine events were judged to be “highly preventable”.(This does not mean they were easy to prevent but that the evidence of preventability was considered to be “virtually certain”) However, 11 of these record only mismanagement without mention of any resulting event.In 9 others evidence of preventability was at least arguable.

    Consider only two examples : Case 1, “Acute on chronic renal failure caused by NSAIDS”. Obviously, without NSAIDS there would have been no renal failure, and in this sense it was “preventable”. But surely NSAIDS, which are known to have adverse reactions, are sometimes indicated. It is surely only when reactions follow their inappropriate use that they can be considered “preventable”. Or Case 32, “Hepatitis caused by lipid-lowering drugs in patient with chronic pancreatitis and familial hypercholesterolemia”. Even if this were an example of a lipid-lowering drug causing hepatitis, how else should one treat familial hypercholesterolemia? An AE following the appropriate use of a necessary drug is surely not preventable.

    In conclusion, this study should stimulate further efforts to diminish the frequency of preventable adverse events associated with hospitalization. However,careful reading is necessary to avoid overestimation of the risk experienced by a hospitalized patient.

    Maurice McGregor McGill University Health Center Montréal, Qc.

    References Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, Etchells E, Ghali WA, Hébert P, Majumdar SR, O’Bierne M, Palacois-Derflingher L, Reid RJ, Sheps S, Tamblyn R. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ 2004; 170(11):1678-88.

    Conflict of Interest:

    None declared

    Show Less
    Competing Interests: None declared.
  • Posted on: (1 June 2004)
    Adverse Events in Canadian Hospitals: The Tip of the Iceberg
    • Peter J. Zed & Richard S. Slavik

    We read with interest the study by Baker et al. characterizing adverse events (AEs) in Canadian hospitals.(1) We applaud the investigators for performing this study and attempting to address the impact of AEs in institutional practice. However, despite the use of a methodology which has been used in other countries to characterize this problem, we feel the use of this methodology has underestimated the impact of advers...

    Show More

    We read with interest the study by Baker et al. characterizing adverse events (AEs) in Canadian hospitals.(1) We applaud the investigators for performing this study and attempting to address the impact of AEs in institutional practice. However, despite the use of a methodology which has been used in other countries to characterize this problem, we feel the use of this methodology has underestimated the impact of adverse drug events in Canadian hospitals.

    First, based on the 18 predefined criteria used in stage 1, adverse drug reaction (ADR) was the only unique criterion used to screen patients with possible drug-related adverse events. Using the pharmaceutical care model established by Hepler and Strand and practiced by many clinical pharmacists in the hospital setting, ADRs represents only one of eight possible drug-related problems (DRPs) that may constitute an AE.(2) Others DRPs such as too much/little drug, wrong drug, drug with no indication, untreated indication, non-compliance and drug interaction would not have been captured using initial screening criterion utilized in stage 1. As a result many patients, who may have been experiencing AEs secondary to medications for reasons other than ADRs, would not have been reviewed in stage 2, and not captured in the final data. We appreciate that some of the above DRPs may have been identified in stage 2, but the absence of clearly established a priori screening criteria for identifying patients with drug-related AEs other than ADRs may underestimate the incidence of drug-related AEs in Canadian hospitals.

    Second, the impact of AEs in the emergency department (ED) was also not evaluated in this study, despite the substantial impact of drug- related ED visits.(3) In a well designed prospective trial, Tafeshi et al. estimated that 28% of all ED visits were drug-related of which 70% were deemed preventable.(4) Although we appreciate that the Canadian Adverse Events Study attempted to characterize the impact of AEs in hospitalized patients, the omission of a highly acute and heterogeneous patient population in the ED will contribute to underestimation of this problem in Canada. With the ongoing issues of ED overcrowding and longer wait times in our country, one can only postulate that the impact of AEs in the ED may be higher than ever and needs to be further evaluated.(5)

    As the investigators clearly outline, this study is just the starting point for understanding the incidence of AEs and the burden of injury resulting from AEs in Canadian acute care hospitals. Further prospective research is clearly needed to more accurately characterize this problem and provide more accurate estimates on AEs in all patient care areas of Canadian hospitals. This will better enable us to efficiently establish systems and allocate key resources to reduce AEs for Canadian patients.

    References

    1. Baker GR, Norton PG, Flintoft V, Blaise R, Brown A, Cox J, et al. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ 2004;170:1678-86.
    2. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm 1990;47:533-43.
    3. Patel P, Zed PJ. Drug-related visits to the emergency department: how big is the problem? Pharmacotherapy 2002;22:915-23.
    4. Tafreshi MJ, Melby MJ, Kaback KR, Nord TC. Medication-related visits to the emergency department: a prospective study. Ann Pharmacother 1999;33:1252-7.
    5. Canadian Association of Emergency Physicians, National Emergency Nurses Affiliation. Joint position statement on emergency department overcrowding. Can J Emerg Med 2001;3:82-4

    Conflict of Interest:

    None declared

    Show Less
    Competing Interests: None declared.
  • Posted on: (31 May 2004)
    The Canadian Adverse Events Study
    • J A Chris Delaney

    In a recent CMAJ study (1) there was a contrast of the rate of adverse events in Canada with those seen in other countries. Interestingly, the rate was lower in the United States and higher in Canada, Britain, Australia and New Zealand (1).

    However, the differences between countries may be due more to differences in medical systems rather than in the actual quality of patient care. The US has a very differe...

    Show More

    In a recent CMAJ study (1) there was a contrast of the rate of adverse events in Canada with those seen in other countries. Interestingly, the rate was lower in the United States and higher in Canada, Britain, Australia and New Zealand (1).

    However, the differences between countries may be due more to differences in medical systems rather than in the actual quality of patient care. The US has a very different medical environment, partially because of the highly litigious nature of US culture (2). The fear of being sued may reduce the incidence of hindsight bias (3) in studies based in the United States since physicians may order more tests than are strictly necessary making it more difficult to “second guess” their decisions.

    It is also the case that people of lower socioeconomic status consume more medical resources than the wealthy (4). It may be that economically disadvantaged people with complex ailments cannot obtain care in the US. As these people are more likely than average to be at risk of an adverse event, this difference might reduce the apparent AE rate in the US because these people never receive care at all.

    So we should be cautious in doing comparisons between AE rates in the US and Canada. These differences could be partially explained by differences in the medical culture and may not be well captured by these types of studies.

    J A Chris Delaney, MSc, Statistician, Department of Clinical Epidemiology, Royal Victoria Hospital, Montreal, Que

    Mark Palko, MSc, Statistician, Atlanta, GA, USA

    Andrei SP Brennan, MA, Research Ethics Quality Assurance Officer, Research Institute of the McGill University Health Centre, Montréal, Que

    1. Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, Etchells E, Ghali WA, Hebert P, Majumdar SR, O'Beirne M, Palacios-Derflingher L, Reid RJ, Sheps S and Tamblyn R. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ. 2004;170(11):1678-86.

    2.Abood S and Tehan T. Medical malpractice crisis. Am J Nurs. 2003 ;103(5):29.

    3. Hebert PC, Levin AV and Robertson G. Bioethics for clinicians: 23. Disclosure of medical error. CMAJ. 2001;164(4):509-13.

    4. Roos NP, Forget E, Walld R and MacWilliam L. Does universal comprehensive insurance encourage unnecessary use? Evidence from Manitoba says "no". CMAJ. 2004;170(2):209-14.

    Conflict of Interest:

    None declared

    Show Less
    Competing Interests: None declared.
  • Posted on: (26 May 2004)
    Prevention of hospital adverse events
    • Ediriweera B.R., Desapriya

    Baker G.R., et al; (2004) study showed that an estimated 7.5% of patients admitted to acute care hospitals in Canada in the fiscal year 2000 experienced 1 or more (adverse Event) AEs. Patient safety is receiving growing attention in Canada. Numerous legal cases and media stories have highlighted the consequences of unintended adverse events (AEs)(1).

    The view expressed by Baker, G.R., et al; adopts and reinfor...

    Show More

    Baker G.R., et al; (2004) study showed that an estimated 7.5% of patients admitted to acute care hospitals in Canada in the fiscal year 2000 experienced 1 or more (adverse Event) AEs. Patient safety is receiving growing attention in Canada. Numerous legal cases and media stories have highlighted the consequences of unintended adverse events (AEs)(1).

    The view expressed by Baker, G.R., et al; adopts and reinforces a social intolerance towards "adverse events" as being events that have an innocent origin (1). Action to reduce clinical risk should not include punitive actions against the people who make the mistakes, but rather action on the systems in which the mistake occurred (2). In the complex environment of acute health, it is very common and surprisingly simple for medical errors to occur. The health care system is significantly behind other high-risk industries in its attention to ensure basic safety. The key behind reducing clinical errors is to make it difficult to do the wrong thing, and easy to do the right thing (3). A profound change in the culture surrounding medical error that is shifting the emphasis from silence to safety is the goal of a new program at Canada, Vancouver’s St. Paul’s Hospital the only Canadian centre participating in a collaborative project of the Boston-Based Institute for Healthcare Improvement (4).

    This “culture of safety” is essential to allay public health community fears and reprisals not only in UK but also in other countries as well. In the UK, meanwhile, a mandatory no-name, no-blame national system for reporting “failures, mistakes and near misses” has been implemented under the National Patient Safety Agency by the end of 2002. It is time now that we should take some initiatives to see early effects of these programs on the quality of overall patient safety and evaluate effects of these programs on future medical error prevention efforts not only in developed countries but also in developing countries as well.

    (1). Baker G.R., et al; The Canadian Adverse events study: the incidence of adverse events among hospitals patients in Canada. CMAJ 2004; 170 (11)

    (2).Holbrook, J., The criminalization of fatal medical mistakes. BMJ 2003; 327:1118-1119.

    (3). Mission, J., A review of clinical risk management. Qual. Clin. Pract. 2001; 4:131-134.

    (4). Kent, H., Talking about errors instead of hiding them goal of Vancouver hospital. CMAJ 2002; 4; 166-167.

    Conflict of Interest:

    None declared

    Show Less
    Competing Interests: None declared.
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The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada
G. Ross Baker, Peter G. Norton, Virginia Flintoft, Régis Blais, Adalsteinn Brown, Jafna Cox, Ed Etchells, William A. Ghali, Philip Hébert, Sumit R. Majumdar, Maeve O'Beirne, Luz Palacios-Derflingher, Robert J. Reid, Sam Sheps, Robyn Tamblyn
CMAJ May 2004, 170 (11) 1678-1686; DOI: 10.1503/cmaj.1040498

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The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada
G. Ross Baker, Peter G. Norton, Virginia Flintoft, Régis Blais, Adalsteinn Brown, Jafna Cox, Ed Etchells, William A. Ghali, Philip Hébert, Sumit R. Majumdar, Maeve O'Beirne, Luz Palacios-Derflingher, Robert J. Reid, Sam Sheps, Robyn Tamblyn
CMAJ May 2004, 170 (11) 1678-1686; DOI: 10.1503/cmaj.1040498
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