Chester Clinic

 

Pts20344 122.128

A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care John T. James, PhD the national level. The amount of new knowledge generated Objectives: Based on 1984 data developed from reviews of medical each year by clinical research that applies directly to patient care records of patients treated in New York hospitals, the Institute of Med- can easily overwhelm the individual physician trying to opti- icine estimated that up to 98,000 Americans die each year from medical mize the care of his patients.1 Furthermore, the lack of a well- errors. The basis of this estimate is nearly 3 decades old; herein, an integrated and comprehensive continuing education system in updated estimate is developed from modern studies published from the health professions is a major contributing factor to knowl- 2008 to 2011.
edge and performance deficiencies at the individual and system Methods: A literature review identified 4 limited studies that used level.2 Guidelines for physicians to optimize patient care are primarily the Global Trigger Tool to flag specific evidence in medical quickly out of date and can be biased by those who write the records, such as medication stop orders or abnormal laboratory results, guidelines.3Y5 At the system level, hospitals struggle with staff- which point to an adverse event that may have harmed a patient. Ulti- ing issues, making suitable technology available for patient care, mately, a physician must concur on the findings of an adverse event and and executing effective handoffs between shifts and also between then classify the severity of patient harm.
inpatient and outpatient care.6 Increased production demands in Results: Using a weighted average of the 4 studies, a lower limit of cost-driven institutions may increase the risk of preventable ad- 210,000 deaths per year was associated with preventable harm in hos- verse events (PAEs). The United States trails behind other devel- pitals. Given limitations in the search capability of the Global Trigger oped nations in implementing electronic medical records for its Tool and the incompleteness of medical records on which the Tool de- citizens.7 Hence, the information a physician needs to optimize pends, the true number of premature deaths associated with preventable care of a patient is often unavailable.
harm to patients was estimated at more than 400,000 per year. Serious At the national level, our country is distinguished for its harm seems to be 10- to 20-fold more common than lethal harm.
patchwork of medical care subsystems that can require patients Conclusions: The epidemic of patient harm in hospitals must be taken to bounce around in a complex maze of providers as they seek more seriously if it is to be curtailed. Fully engaging patients and their effective and affordable care. Because of increased production advocates during hospital care, systematically seeking the patients' demands, providers may be expected to give care in suboptimal voice in identifying harms, transparent accountability for harm, and working conditions, with decreased staff, and a shortage of intentional correction of root causes of harm will be necessary to ac- physicians, which leads to fatigue and burnout. It should be no complish this goal.
surprise that PAEs that harm patients are frighteningly common Key Words: patient harm, preventable adverse events, transparency, in this highly technical, rapidly changing, and poorly integrated patient-centered care, Global Trigger Tool, medical errors industry. The picture is further complicated by a lack of trans-parency and limited accountability for errors that harm patients.8,9 (J Patient Saf 2013;9: 122Y128) There are at least 3 time-based categories of PAEs recog- nized in patients that are or have been hospitalized. The broadestdefinition encompasses all unexpected and harmful experiencethat a patient encounters as a result of being in the care of amedical professional or system because high quality, evidence-based medical care was not delivered during hospitalization. Theharmful outcomes may be realized immediately, delayed for days ‘‘All men make mistakes, but a good man or months, or even delayed many years. An example of immediate yields when he knows his course is wrong, harm is excess bleeding because of an overdose of an anticoagu-lant drug such as that which occurred to the twins born to Dennis and repairs the evil. The only crime is Quaid and his wife.10 An example of harm that is not apparent pride.''V Sophocles, Antigone'' for weeks or months is infection with Hepatitis C virus as a resultof contaminated chemotherapy equipment.11 Harm that occursyears later is exemplified by a nearly lethal pneumococcal infec-tion in a patient that had had a splenectomy many years ago, yetwas never vaccinated against this infection risk as guidelines andprompts require.12 Medical care in the United States is technically complex at the individual provider level, at the system level, and at From the Patient Safety America, Houston, Texas.
The approach to the problem of identifying and enumer- Correspondence: John T. James, PhD, Patient Safety America, ating PAEs was 4-fold: (1) distinguish types of PAEs that may 14503 Windy Ridge Lane, Suite 200, Houston, TX 77062 occur in hospitals, (2) characterize preventability in the context of the Global Trigger Tool (GTT), (3) search contemporary The author discloses no conflict of interest.
medical literature for the prevalence and severity of PAEs that Sources of support: none.
Copyright * 2013 by Lippincott Williams & Wilkins have been enumerated by credible investigators based on medical J Patient Saf & Volume 9, Number 3, September 2013 Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
J Patient Saf & Volume 9, Number 3, September 2013 Patient Harms Associated with Hospital Care records assessed by the GTT, and (4) compare the studies found preventable.''18 The GTT depends on systematic review of by the literature search.
medical records by persons trained to find specific clues ortriggers suggesting that an adverse event has taken place. For example, triggers might include orders to stop a medication, an The cause of PAEs in hospitals may be separated into these abnormal lab result, or prescription of an antidote medication such as naloxone. As a final step, the examination of the recordmust be validated by 1 or more physicians. As will be shown & Errors of commission, shortly, the methods used to find adverse events in hospital & Errors of omission, medical records target primarily errors of commission and are & Errors of communication, much less likely to find harm from errors of omission, com- & Errors of context, and munication, context, or missed diagnosis.19 There are some & Diagnostic errors overlaps in these categories and cascades of harmful events canensue from a single root cause. A ‘‘perfect storm'' of unrec- These distinctions are important because investigators ognized but correctable medical errors can result in serious searching for preventable harm must be aware of what they can harm or death.15,20 find and what they cannot find. The easiest error to detect inmedical records is an error of commission. This occurs when a Literature Search mistaken action harms a patient either because it was the wrong Our literature search included the following three terms: action or it was the right action but performed improperly. For medical error, global trigger tool, and hospital. We searched example, the patient may need his gall bladder removed, but Pub Med and ‘‘reports and publications'' from the government during the surgery, the intestine is nicked, and the patient de- Web site Those searches turned up 20 articles velops a serious infection, such as was alleged to be the cause published between 2006 and 2012, of which, 4 were found to be leading to the death of Representative John Murtha. Errors of suitable for the present analysis. The unsuitable studies included omission can be detected in medical records when an obvious studies of populations outside the United States, studies con- action was necessary to heal the patient, yet it was not per- fined to narrow hospital populations (e.g., intensive care unit), formed at all. For example, a patient may need a A-blocker, but studies of ambulatory patients, studies involving only method- because it was not prescribed, the patient died prematurely.13 ological comparisons, adverse-event issue papers, failures of Errors of omission because of failure to follow evidence-based incident reporting systems, and studies that did not classify the guidelines are much more difficult to detect, partly because severity of the harm associated with adverse events.
there are many complex guidelines and also because adverseconsequences of failure to follow guidelines may be delayed Characterization of the Core Studies until after discharge.14,15 The 4 key studies were reviewed for similarity and differ- Errors of communication can occur between 2 or more ence in methods used to find adverse events. It was found that providers or between providers and patient. One example of a each one employed similar methods to flag, confirm, and then lethal error of communication between provider and patient classify adverse events according to level of harm. All studies occurred when cardiologists failed to warn their 19-year-old used a 2-tier approach that consisted of screening of medical patient not to run. The patient had experienced syncope while records by nonphysicians, usually nurses or pharmacists, to flag running, and 5 days of inpatient, diagnostic testing were in- suspect events. In the second tier, physicians examined the conclusive; however, his cardiologists knew he was not ready suspect events to determine if a genuine adverse event had oc- to return to running but failed to warn him against this risk.
curred and, if so, the level of seriousness of the event. In all Having not been warned against running, he resumed running studies, the GTT from the Institute for Healthcare Improvement and died 3 weeks later while running.15 was the primary screening tool;21 however, there were variations Contextual errors occur when a physician fails to take into in the supplementary tools used to detect potential adverse events.
account unique constraints in a patient's life that could bear on A 2008 pilot study by the Office of Inspector General successful, postdischarge treatment. For example, the patient (OIG) of the Department of Health and Human Services used may lack the cognitive ability to comply with a medical treat- 5 methods in its search for adverse eventsVnurse reviews using ment plan or may not have reasonable access to follow-up the GTT, conditions that were not present on admission (POA), care.16 Diagnostic errors resulting in delayed treatment, the beneficiary interviews, hospital incidence reports, and patient wrong treatment, or no effective treatment may also be con- safety indicators.22 The pilot study revealed that the GTT cap- sidered separately, although a small subset of these might be tured the highest percentage (78%) of the events ultimately included as errors of commission or omission. For example, a deemed to be adverse events in the second tier review by phy- diagnostic error may lead to harm from errors of commission by sicians. The use of POA indicator codes was second best at overtreatment or mistreatment of the patient until the mistake is 61%. Together, these methods were found to identify 94% of discovered. The apparent eagerness of the U.S. health-care in- the flags that led physicians to declare that an adverse event dustry to over diagnose patients often leads to harmful conse- had taken place. A more comprehensive OIG study in 2010 quences for patients.17 employed these 2 screening methods and a third based onwhether the patient had been readmitted to the hospital with Preventability and the Global Trigger Tool 30 days of discharge from the last discharge during the October The prevailing view is that ‘‘preventability'' of an adverse 2008 index period.23 event links to the commission of an identifiable error that A study by Classen and colleagues also employed the GTT caused an adverse event. Adverse events that cannot be traced to along with Agency for Healthcare Research and Quality Patient a likely error should not be called ‘‘preventable.'' The portion of Safety Indicators (PSIs) and hospital reports of adverse events.
adverse events that are deemed preventable tends to be about Of the 167 flagged events that ultimately were deemed true 50% to 60%; however, recently, experts have postulated that adverse events by physician review, the GTT detected 90% in virtually all adverse events they identified with the ‘‘GTT are the severity levels F through I (Table 1).18 The longitudinal * 2013 Lippincott Williams & Wilkins Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
J Patient Saf & Volume 9, Number 3, September 2013 TABLE 1. Adverse Events Classified as Serious Required prolonged hospital stay Life sustaining intervention required Contributing to death of patient Adapted from the National Coordinating Council for Medication Errors Reporting and Prevention.
study by Landrigan and colleagues relied on the GTT and POA indicators to flag possible adverse events. Like the other studies, the ultimate determination of a genuine adverse event and the severity of the event were judged by physicians during thesecond-tier analysis.24 Although there are slight variations in the approach used to discover flags in the records examined bythe 4 studies, the GTT was the core method placed in the hands of trained and experienced nurses. All studies used a second tier requiring physicians to determine whether a flag signaled agenuine adverse event and, if so, then assign a severity level to that event. All studies used the National Coordinating Council for Medication Reporting and Prevention scale (Table 1).
Recent data from the 4 key studies provide a more com- prehensive, evidence-based estimate of the number of lethal and serious medical errors than the one provided by the Institute ofMedicine (IOM).25 These data are compiled in Table 2, and the studies are described below.
A pilot study by the OIG was published in 2008 in an effort to explore the effectiveness of search methods for adverse events.21 As noted in the methods section, this study relied on 5 search methods for flagging potential adverse events in medical records but did not specify whether such events were prevent- able. The 278 medical records reviewed by screeners and phy- sicians were not randomly selected to be representative of Medicare hospitalizations; instead, they originated from hospi- tals in 2 unspecified counties. Of the 51 serious adverse events identified, only 3 were on the National Quality Forum's list of serious reportable events and only 11 were on Medicare's HospitalAcquired Condition (HAC) list. In 2010, the OIG estimated ad- verse events in hospitalized Medicare patients.23 Investigators looked at the medical records of 780 ran- domly selected patients chosen to represent the 1 million Medi- care patients ‘‘discharged'' from hospitals in the month of October 2008. The total number of hospital stays for the 780 patients during this period was 838 because some of the ben- eficiaries were hospitalized and discharged more than onceduring the 1-month index period. Using primarily the GTT developed by the Institute for Healthcare Improvement to find adverse events, investigators found 128 serious adverse events (level of harm F, G, H, or I) that caused harm to patients, and an adverse event contributed to the deaths of 12 of those patients.
Seven of these deaths were medication related, 2 were from blood stream infections, 2 were from aspiration, and the 12th one was linked to ventilator-associated pneumonia. Only 2 of these events were on the National Quality Forum list, and none were on the Medicare HAC list. The authors of this report estimated that ‘‘events'' contributed to the deaths of 1.5 % (12/ 780) of the 1 million Medicare patients hospitalized in October 2008. That amounts to 15,000 per month or 180,000 per year.
* 2013 Lippincott Williams & Wilkins Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
J Patient Saf & Volume 9, Number 3, September 2013 Patient Harms Associated with Hospital Care Note that the percentage of deaths per hospitalization was slightly lethal adverse events in tertiary hospitals to be above the na- lower at 1.4% (12/838). The authors did not explicitly state the tional average for all hospitalizations because more complex percentage of the lethal adverse events that were preventable, but illnesses are treated there with longer hospital stays. One would given their description of the events, it seems that most were expect, as the original authors did, that the incidence data from preventable. Overall, physician reviewers estimated that 44% of North Carolina would be below the national average for lethal serious medical events were preventable.
adverse events because of concerted efforts in that state to im- In a somewhat similar study published in March 2011 in prove patient safety in hospitals compared with the average of the journal Health Affairs, investigators examined the medical other states in the United States.
records of 795 patients treated in 1 of 3 tertiary hospitals in It is our opinion that none of the 4 studies alone can pro- the month of October 2004.18 These hospitals had been recog- vide a defensible estimate for hospitals across the United States; nized for their efforts to improve patient safety. The in- however, by combining the studies, an evidence-based estimate vestigators also used the GTT to discover adverse events. They of the number of lethal PAEs across the country can be devel- found 167 adverse events in the categories F through I, and 9 of oped. The most favorable way to combine the 4 studies to find the adverse events contributed to the deaths of patients (cate- the lowest reasonable estimate is to weigh the studies according gory I). Thus, an adverse event contributed to death in 1.1% to how many medical records from a single hospital stay were of these patients. The causes were as follows: procedure re- reviewed by each team of investigators. This means that the lated (not infection)V4, nosocomial infectionV1, pulmonary/ study of patients hospitalized in North Carolina was heavily venous thromboembolismV2, and unspecified otherV2. In- weighted compared with the other studies. Thus, there were a terestingly, none of the deaths were explicitly associated with total of 4252 records reviewed (compiled from Table 2). Among medication errors, which were the primary causes of death in the records reviewed, there were 38 total deaths associated with the Medicare patients studied by the OIG.23 Medication-related adverse events. The ratio projects to a death rate from adverse errors caused 35% of the category-F harms in the Health Affairs events of 0.89%. This is well below the percentages from study.18 The average age of the patients whose records were Medicare and tertiary-care studies (1.1%Y1.4%) and well above examined was 59 years. The 10 authors of the original study did the data from the North Carolina study (0.60%). There were an not formally assess the preventability of errors, declaring in- estimated 34.4 million hospital discharges in 2007,26 and the stead that it is their belief that all adverse events are preventable.
average percentage of preventable adverse events among all In a fourth recent study targeting changes in patient safety in adverse events in the 3 studies where this was reported or pos- 10 hospitals in North Carolina, there was a lower incidence of tulated was 69% (averaged from Table 2). Thus, the best esti- deaths associated with adverse events.24 Hospitals in North Carolina mate from combining these 4 studies is 34,400,000  0.69  were chosen because hospitals in that state had shown a ‘‘high level 0.0089 = 210,000 preventable adverse events per year that con- of engagement in efforts to improve patient safety.'' In that state, tribute to the death of hospitalized patientsVbased primarily on 96% of the hospitals had enrolled in a national campaign to evidence in hospital medical records found by the GTT method.
improve patient safety, whereas the average in other states wasonly 78%. A priori, a lower rate of preventable adverse eventsthan the national average could be expected. The investigators studied the change in incidence of adverse events using the GTT There has been no lack of contention about the prevalence on 10 randomly selected medical records per quarter from the of PAEs, which herein will be considered synonymous with first quarter of 2002 to the last quarter of 2007. The tool was medical errors that cause harm to patients; this does not include applied by internal and external reviewers; however, the internal near misses that do not harm patients.27,28 The first estimate of reviewers had better kappa scores (a measure of agreement) when medical errors that received widespread attention was declared compared with experienced external reviewers, so the results of by the IOM in its now- famous book called ‘‘To Err is Human.''25 internal reviews, which were the only ones given in detail in the The IOM provided 2 estimates of the number of deaths from original paper, will be used here. Based on 2341 admissions and medical errors, but careful inspection of the origin of these es- the finding of 14 cases where adverse events contributed to death, timates show that they were based on data that are now quite the percentage of lethal adverse events was 0.60%. The primary old. The earliest estimate originated from the Harvard Medical causes of death were hospital-acquired infections (HAIs) (7) and Practice Study in which 30,000 randomly selected discharge acute renal failure (2). Other causes are shown in Table 2. This records from 1984 in 51 New York hospitals were examined.29 study involved many more medical records than the OIG or The investigators found that serious adverse events occurred in Health Affairs study, but the hospitals and patients were not se- 3.7% of the hospitalizations. Of the adverse events, 58% were lected to be representative of hospitals around the country. The attributable to error (i.e., they were preventable). Of this frac- hospitals were selected because the investigators felt that North tion, 13.6% resulted in death. Extrapolated to 33.6 million Carolina had made a concerted effort to improve patient safety hospitalizations nationwide in 1997, simple arithmetic yielded over the study period. It is not surprising that the percentage of the following: 33,600,000  0.037  0.136  0.58 = 98,000 serious or lethal adverse events was lower than in the other studies deaths per year. Another study of 15,000 medical records from summarized in Table 2.
Colorado and Utah in 1992 found lower rates of adverse events All 4 studies (Table 2) have similar, 2-tier search methods and death, from which the IOM estimated 44,000 deaths na- to identify serious adverse events. The GTT, supplemented by tionwide per year.25 Although physician reviews reveal adverse other less comprehensive methods, was applied to medical re- events due to ‘‘negligence,'' which was about 28% to 29% in cords by experienced nonphysicians to identify possible adverse both studies, a later publication from the IOM suggested that events, and then, physician reviewers determined which flags the 44,000 to 98,000 deaths did not include errors of omis- were associated with an adverse event. However, the study sion.30 Because the New York study included a larger sample, populations were quite different. One would expect the OIG the deaths-per-year figure of 98,000 attributed to the IOM is the studies of Medicare patients, who tend to have more comor- estimate most often quoted. In fact, the IOM declared that the bidity than the average hospitalized patient, to show the highest ‘‘number of deaths [per year] due to medical error may be as incidence of lethal PAEs. One would expect the incidence of high as 98,000.'' * 2013 Lippincott Williams & Wilkins Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
J Patient Saf & Volume 9, Number 3, September 2013 Why is the present estimate of the number of lethal PAEs scored high (15Y20 points). Furthermore, the larger OIG study so much higher than the highest estimate (98,000) from the noted that ‘‘To the extent that the study did not identify an IOM? It is likely that the bar for identification of a PAE in the event, it was likely because the three screening methods failed New York/IOM study was much higher than in the 4 modern to flag the case for physicians review or because documentation studies and that the GTT is better able to identify adverse events in the medical records was incomplete.''23 than general reviews by physicians, which was the method used A few years after the seminal publication by the IOM, in the older studies cited by the IOM.19 It is also possible that another IOM panel recognized the limitations of using medical the frequency of preventable and lethal patient harms has in- records provided by medical institutions as the basis for iden- creased from 1984 to 2002Y2008 because of the increased tifying medical errors. When an adverse event is alleged and an complexity of medical practice and technology, the increased evaluation is undertaken, the ‘‘sentinel effect can significantly incidence of antibiotic-resistant bacteria, overuse/misuse of med- alter the data that are recorded.''30 There are anecdotal accounts ications, an aging population, and the movement of the medical of data altering or omission of critical data when mistakes are industry toward higher productivity and expensive technology, alleged; however, to our knowledge, scientific studies of this which encourages rapid patient flow and overuse of risky, inva- phenomenon have been lacking until recently.
sive, revenue-generating procedures.31Y33 In a study that broke past the wall of silence about dis- Several observations about the 4 varied studies described covery of medical errors that were missing from medical re- in the ‘‘Results'' section are in order. Although they used varied cords, Weissman and colleagues found that 6 to 12 months after selection criteria for the patient populations and hospitals, the their discharge, patients could recall 3 times as many serious, results in terms of the portion of adverse events found and the preventable adverse events as were reflected in their medical portion of death-associated events are not remarkably varied.
records.14 This study involved review of 998 medical records The percentage of serious adverse events (class F to I) ranged of patients hospitalized in Massachusetts for medical or sur- from 14% to 21%, and the percentage of death-associated ad- gical treatment from April to October 2003. Record reviews by verse events (class I) varied from 0.60% to 1.4%. The result specially trained nurses and doctors identified 11 serious found in records from North Carolina hospitals (0.60%) is likely PAEs from the records. The method was one adapted from to be below the national average because patient safety efforts in the Harvard Medical Practice Study, which is the method used that state have been more intense when compared with other by the core result in the report from the IOM asserting up to states. The results from the other studies would be expected to 98,000 deaths per year occur from medical errors.25 However, be above the national average because of the age of the patients interviews with patients identified 21 additional serious PAEs and seriousness of the illnesses. This dispersion of percentages that were not documented in the medical records. Of the makes sense and gives one confidence that the estimate of the 21 undiscovered, serious PAEs, 12 occurred predischarge and average number of preventable, lethal adverse events based on 9 occurred postdischarge. The predischarge serious PAEs in- hospital medical records screened by the GTT approach is rep- cluded the following: adverse drug events (3), nerve or vessel resentative of the nation as a whole. The portion of serious ad- injury or wrong operation (4), deep venous thrombosis (2), verse events that were not lethal (class F, G, and H) were hospital acquired infection (2), and postoperative respiratory roughly 10- to 20-fold larger than the portion of lethal PAEs.
distress (1). The serious PAEs postdischarge included the fol- This leads to a rough estimate of 2 to 4 million serious, PAEs lowing: wound infection (6), deep venous thrombosis (1), op- per year that would be discoverable in medical records using the erative wound dehiscence (1), and operative organ injury (1).
GTT approach.
Even in this study, the investigators found only those errors There are important limitations to the 4 modern studies that that patients were aware had happened. There certainly may be must be considered. Premature deaths as a result of medical more serious errors that went undocumented and were un- errors may occur many years after the hospital stay because the known to patients. Weismann's finding that evidence of many patient's care was not optimal or did not follow guidelines.12 serious adverse events is not apparent in medical records is Furthermore, lethal PAEs can been missed by the GTT and by reinforced by some older studies. For example, it has been physician reviews. The GTT does not detect diagnostic errors or pointed out that some medical errors are not known by clini- errors of omission, especially those involving failure to follow cians and only come to light during autopsies, which have guidelines.19 Lethal diagnostic errors have been estimated to found misdiagnoses in 20% to 40% of cases.38 ‘‘Aggressive'' affect 40,000 to 80,000 people per year including outpatients.34 searches for adverse drug events and prompted self-reports Physicians have been indefensibly slow to adopt guidelines that from clinicians have shown a much higher rate of adverse would potentially prevent premature deaths or harm.35 One drug events than are evident in the medical records.39 A com- egregious example is the estimated 100,000 heart failure pa- parison of direct observation for medication errors with review tients that died prematurely each year in the late 1990s because of documentation in medical records in 36 hospitals and they did not receive beta-blockers.13 The efficacy of beta- skilled-nursing facilities found that far more errors were found blockers was established by a study published in the JAMA by direct observation than by inspection of medical records.40 A recent national survey showed that physicians often re- The 4 modern studies also rely heavily on information in fuse to report a serious adverse event to anyone in authority.41 medical records. One study of medical records showed that In the case of cardiologists, the highest nonreporting group of quality scores of 607 randomly selected medical records on the specialties studied, nearly two-thirds of the respondents cardiac patients treated in 219 hospitals from January 2004 to admitted that they had recently refused to report at least one June 2005 averaged 12.5/20 points, which suggests rather poor serious medical error, of which they had first-hand knowledge, medical record keeping.37 The quality scores were determined to anyone in authority. It is reasonable to suspect that clear based on the medical records including cardiac history, perfor- evidence of such unreported medical errors often did not find mance and cognition levels, current medications and medication their way into the medical records of the patients who were allergies, differential diagnosis, and planned use of evidence- based medicine. Hospitals with low-scoring records (0Y10 The bottom line on total, lethal PAEs as a result of care in points) had a 40% higher in-hospital death rate than those that hospitals cannot be estimated in a statistically rigorous way.
* 2013 Lippincott Williams & Wilkins Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
J Patient Saf & Volume 9, Number 3, September 2013 Patient Harms Associated with Hospital Care Based on our extrapolation from the 4 modern studies, there are 2. IOM (Institute of Medicine). Redesigning Continuing Education at least 210,000 lethal PAEs detectable by the GTT approach to in the Health Professions. Washington, DC: The National Academies record reviews. To deal with other factors that should be applied Press; 2010.
to this estimate, the ‘‘weight of evidence'' approach must be 3. Sniderman AD, Furberg CD. Why guideline-making requires reform.
engaged. In addition to the core estimate of 210,000, one must consider evidence of the following: 4. Ferket BS, Colkesen EB, Visser JJ, et al. Systematic review of guidelines & life-shortening errors of omission due to failure to follow on cardiovascular risk assessment. Arch Intern Med. 2010;170:27Y40.
medical guidelines that the GTT approach misses,19 & a factor for evidence of errors of commission that are not 5. Mendelson TB, Meltzer M, Campbell EG, et al. Conflicts of interest in cardiovascular clinical practice guidelines. Arch Intern Med.
documented in medical records,37,39 & failure to make life-saving diagnoses.38 6. Gittell JH. High Performance HealthcareVUsing the Power of In light of the evidence above, and especially that of the Relationships to Achieve Quality, Efficiency and Resilience. New York, Weisman study,14 and although it is probably an underestimate, NY: McGraw Hill; 2009 a minimum estimate of a 2-fold increase in the medical 7. American College of Physicians. Achieving a high performance health recordYbased estimate is reasonable to compensate for the care system with universal access: What the United States can learn known absence of evidence in medical records of errors of from other countries. Ann InternMed. 2008;148:55Y75.
commission and the inability of the GTT to detect errors ofomission even when the evidence that guidelines were not 8. Reid, RO, Friedberg MW, Adams JL, et al. Associations between followed may be present in the medical record. Note that the physician characteristics and quality of care. Arch Intern Med.
Weisman study suggests a factor of 3 (32/11) for undocumented evidence of serious PAEs caused during hospitalization, but 9. Levinson DR. Hospital Incident Reporting Systems Do Not Capture here, we settle for a factor of 2.14 To this, one should add the Most Patient Harm. DHHS, OIG. 2012, OEI-06-09-00091.
undetected diagnostic errors. If we begin with the minimum 10. California Injury Lawyers Blog. Available at: estimate of 40,000 and assume that only half of these occur in hospitals, then the math looks like this: (210,000  2) + 20,000 440,000 PAEs that contribute to the death of patients each Accessed July 12, 2012.
year from care in hospitals. This is roughly one-sixth of all 11. McKnight EV, Bennington TT. A Never EventVExposing the Largest deaths that occur in the United States each year. The problem of Outbreak of Hepatitis C in American Healthcare History. Fremont, NE: PAEs must emerge from behind the ‘‘Wall of Silence'' and be History Examined, LLC; 2010 addressed for the sake of prolonging the lives of Americans.
12. Ghandi TK, Zuccotti G, Lee TH. Incomplete careVOn the trail of flaws Needed changes involve not only doctors and hospitals but in the system. N Engl J Med. 2011:365:486Y488.
increased participation by patients in their health-care decisions.
Perhaps it is time for a national patient bill of rights for hospi- 13. Gheorghaide M, Gattis WA, O'Conner CM. Treatment gaps in the talized patients that would empower them to be thoroughly in- pharmacologic management of heart failure. Rev Cadiovasc Med.
2002;3:S11 tegrated into their care so that they can take the lead in reducing their risk of serious harm and death.15 All evidence points to the 14. Weismann JS, Schneider EC, Weingart SN, et al. Comparing need for much more patient involvement in identifying harmful patient-reported hospital adverse events with medical records reviews: events and participating in rigorous follow-up investigations to Do patients know something that hospitals do not? Ann Intern Med.
identify root causes.42 Even for those harms identified in the medical records of Medicare patients, only 14% become part of 15. James JT. A Sea of Broken HeartsVPatient Rights in a Dangerous, the hospital's incident reporting system.9 Physician observers of Profit-Driven Health Care System. Bloomington, IN: our hospitals have made Congress painfully aware that the AuthorHouse; 2007.
hospital peer-review system has widespread failures that permit 16. Weiner SJ, Schwartz A, Weaver F, et al. Contextual errors and failures in negligent care by physicians.43 Hospitals are simply not going individualizing patient care. Ann Intern Med. 2010;153:69Y75.
to heal without attentive, systematic listening to those harmed 17. Welch HG, Schwartz LM, Woloshin S. Over-diagnosedVMaking patients or their survivors.
People Sick in the Pursuit of Health. Boston, MA: Beacon Press; 2011.
18. Classen, DC, Resar R, Griffin F, et al. ‘‘Global trigger tool'' shows that adverse events in hospitals may be ten times greater than previously There was much debate after the IOM report about the measured. Health Aff. 2011;30:581Y589.
accuracy of its estimates. In a sense, it does not matter whether 19. Parry G, Cline A, Goldmann D. Deciphering harm measurement.
the deaths of 100,000, 200,000 or 400,000 Americans each year are associated with PAEs in hospitals. Any of the estimatesdemands assertive action on the part of providers, legislators, 20. Walter D. Collateral DamageVA Patient, a New Procedure, and the and people who will one day become patients. Yet, the action Learning Curve. Charleston, SC: CreateSpace; 2010.
and progress on patient safety is frustratingly slow; however, 21. Institute for Healthcare Improvement. IHI Global Trigger Tool Guide.
one must hope that the present, evidence-based estimate of Cambridge MA, 2008. Available at: 400,000+ deaths per year will foster an outcry for overdue changes and increased vigilance in medical care to address the July 12, 2012.
problem of harm to patients who come to a hospital seeking 22. Department of Health and Human Services, Office of the Inspector only to be healed.
General. Adverse Events in Hospitals: Case Study of Incidence amongMedicare Beneficiaries in Two Selected Counties. Washington, DC; 2008, Available at: .
1. Zilberberg MD. The clinical research enterpriseVtime to change 23. Department of Health and Human Services, Office of the Inspector course? JAMA. 2011;305:604Y605.
General. Adverse Events in Hospitals: National Incidence among * 2013 Lippincott Williams & Wilkins Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
J Patient Saf & Volume 9, Number 3, September 2013 Medicare Beneficiaries. Washington, DC; 2010, Available at: 34. Newman-Toker DE, Pronovost PJ. Diagnostic errorsVthe next frontier for patient safety. JAMA. 2009;301:1060Y1062.
24. Landrigan, CP, Parry GJ, Bones CB, et al. Temporal trends in rates of 35. Kotchen TA. Why the slow diffusion of treatment guidelines into patient harm resulting from medical care. N Engl J Med.
clinical practice? Arch Intern Med. 2007;167:2394Y2395.
36. A randomized trial of propranolol in patients with acute myocardial 25. IOM (Institute of Medicine). To Err is HumanVBuilding a Safer Health infarction. I. Mortality results. JAMA. 1982;247:1707Y14. Available at: System. Washington, DC: The National Academies Press; 2000.
26. Hall MJ, DeFrances CJ, Williams SN, et al. National Health 37. Dunlay SM, Alexander KP, Melloni C, et al. Medical records and quality Statistics Report. CDC Report Number 29; 2010. Available at: of care in acute coronary syndromes. Arch Intern Med. 2008; 27. Hayward RA, Hofer TP. Estimating hospital deaths due to medical errors. JAMA. 2001;286:415Y420.
38. Leape L. Institute of Medicine medical error figures are not 28. Goodman JC, Villarreal P, Jones B. The social cost of adverse medical exaggerated. JAMA. 2000;284:95Y97.
events, and what we can do about it. Health Aff. 2011;30:590Y595.
39. Weingart SN, Wilson RM, Gibberd RW, et al. Epidemiology of medical 29. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events error. BMJ. 2000:320:774Y777.
and negligence in hospital patients: results of the Harvard Medical 40. Flynn EA, Barker KN, Pepper GA, et al. Comparison of methods for Practice Study. N Engl J Med. 1991;324:370Y376.
detecting medication errors in 36 hospitals and skilled-nursing 30. IOM (Institute of Medicine). Patient SafetyYAchieving a New Standard facilities. Am J Health-System Pharm. 2002;59:436Y446.
of Care. Washington, DC: The National Academies Press; 2004.
41. Campbell EG, Regan S, Gruen RL, et al. Professionalism in medicine: 31. Moody J, Cosgrove SE, Olmsted R, et al. Antimicrobial stewardship: a results of a national survey of physicians. Ann Intern Med. 2007; collaborative partnership between infection preventionists and healthcare epidemiologists. Infect Control Hosp Epidemiol.
2012;33:328Y330.
42. Junya Z, Struver S, Epstein A, et al. Can we rely on patients' reports of adverse events? Med Care. 2011;49:948Y955.
32. Schneider EL, Campese VM. Adverse drug responses, an increasing threat to the well- being of older patients. Arch Intern Med.
43. Rogan GN, Sebat F, Grady I. How Peer Review Failed at Redding Medical Center, Why It Is Failing Across the Country and What Can 33. Stergiopoulos K, Brown DL. Initial coronary stent implantation with be Done About It. Congressional Report, June 1, 2008. Available at: medical therapy vs medical therapy alone for stable coronary artery disease. Arch Intern Med. 2012;172:312Y319.
July 12, 2012.
* 2013 Lippincott Williams & Wilkins Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Source: http://www.cohsasa.co.za/sites/cohsasa.co.za/files/patient_safety_pdfs/a_new_evidence_based_estimate_of_patient_harms.2.pdf