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Medical Error Epidemic Hysteria
COMMENTARY
Medical Error Epidemic Hysteria Medical errors are taken very seriously by our profession. This starts early in training at the Morbidity and Mortality Conference. The cases are scrutinized and criticized to see what could have been done better. No one likes to see complications or deaths, especially not physicians. So how can medical errors have become the “third leading cause of death,” as trumpeted in a recent editorial in the BMJ (formerly known as the British Medical Journal)?1 Where are those hundreds of thousands of casualties every year? The actual number of patient deaths analyzed according to the authors, over a period of approximately 10 years, was 35. I have been on 5 medical journal editorial boards and reviewed articles for 24 different journals over the past 30 years. Given what I know, I never would have agreed to have this sensationalist article published. Furthermore, the way it was reported in the general news media was irresponsible. This was NOT a scientific study at all, but only an opinion piece. It presented NO new research, it was not peer reviewed, and the studies relied on for data were not new. The article by Makary and Daniel1 simply states the average of 2 previously published studies and 2 articles that were never vetted through the peer review process, all published more than 8 years ago.2-5 All 4 of these articles include a combined analysis of a grand total of only 35 actual patients (from 2000-2008), from which the authors extrapolate to 251,454 deaths due to medical errors in the United States every year—representing 35% of all hospital deaths. This is a highly dubious estimate. On review of the 4 primary studies quoted in the BMJ article,1 I can find only 14 preventable medical error deaths (using their definition of the term), not the 35 quoted in the BMJ article. This obviously would have profound implications on the extrapolation results. No, as a peer reviewer, I would not have recommended publication of the BMJ article. As an editor, I would have at the very least sent it back asking for “major revision.”
Funding: None. Conflict of Interest: None. Authorship: The author had access to the data and played a role in writing this manuscript. Requests for reprints should be addressed to Gerard J. Gianoli, MD, The Ear and Balance Institute, 1401 Ochsner Blvd, Suite A, Covington, LA 70433. E-mail address: [email protected] 0002-9343/$ -see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjmed.2016.06.037
In research, much depends on definitions. Consider the case of someone falling from a tree. In running to catch him, you trip over a stone. The person hits the ground and dies. Did your tripping over the stone cause that person’s death or was it the fall? According to the reasoning behind the BMJ article,1 the death was your fault. No distinction is made from unintended actions and intended actions, performed well, resulting in undesired outcomes, that is, complications. When a patient was sent home from an emergency department in Dallas with Ebola last year, this was an error probably caused by electronic medical record-related disruption.6 The patient later returned and died. But he probably would have died even if this “systems” error had not occurred. The 1 case presented in the article by Makary and Daniel1 concerns a patient who died of complications from pericardiocentesis. This procedure has risks. This was not a medical error, but a known complication that can occur even when everything is done perfectly by the most competent of physicians. While proposing that iatrogenic deaths are underestimated, the authors never admit that death would be inevitable in most of these cases without medical intervention, and the margin of error in critically ill patients often is razor thin. Sadly, sometimes, even when everything is done perfectly by the best in the world, the outcome is still death. Extrapolation is a dangerous thing. Whenever one extrapolates from a study group, you must be sure that it is a “representative sample” of the group to which you are extrapolating. In this case, the authors of the BMJ article1 extrapolate from 2 studies that comprise exclusively Medicare patients and 2 studies that comprise only patients aged more than 18 years, excluding psychiatric admits, rehabilitation admits, and pediatric cases. Keep in mind that approximately 75% of all hospital deaths occur in those aged more than 65 years, and less than 6% of deaths are in those aged less than 40 years. Drew Brees is the all-time National Football League career record holder in pass completion at approximately 70%. Extrapolating from this group is similar to trying to extrapolate Drew Brees’ completion record while only using his completion success on Hail Mary passes (<5%). The extrapolation fails miserably because it is not a representative group. The BMJ article1 tries to extrapolate “medical Hail Marys” to the general medical population. This is probably why the authors of the quoted studies never extrapolated their findings to the general medical public—because it was inappropriate.
2 Makary and Daniel1 recommend changing death certificates to include a check box for “medical error death” instead of using International Classification of Diseases codes. This recommendation is misinformed because no one uses International Classification of Diseases codes on death certificates. There is a place to list “cause of death”—the physiologic reason the patient died, as well as subsequent lines for cascading events—and there is a place to list “manner of death”—homicide, suicide, accident, natural causes, and so forth. So, in essence, there already is a place to list medical error, both in the manner and cause sections.7 However, death certificates are essentially a best guess as to why someone died. If the authors of the BMJ article1 want an accurate assessment of why patients die, they should be recommending autopsies. Studies have found that 25% to 60% of death certificates are inaccurate compared with autopsy findings.8-11 Although autopsy rates were 50% in the 1970s, they have dwindled down to less than 5% currently.12 While the media is being hyped up about “increasing rates” of medical error deaths (there is no evidence that is the case), the actual total number of deaths in hospitals have been on the decline. The Centers for Disease Control and Prevention lists the number of total deaths in hospitals at 776,000 in 2000 with a slow steady decline to 715,000 in 2010.13 This decline in total hospital deaths has occurred despite increased hospital admissions in an aging population for whom the less complex surgical cases have been shifted out of hospitals to surgery centers. In other words, we are seeing substantial improvement in overall hospital mortality despite increasing complexity. The problem is getting better, not worse. The article by Makary and Daniel1 may turn out to be the “silicone breast implant hysteria” of our generation. In the 1980s and 1990s, there was much hype about silicone breast implants causing an epidemic of medical ills. The hysteria surrounding this was fueled by the Food and Drug Administration, the media, and the plaintiff’s attorneys. As a result, many implants were removed without medical justification, undeserved money went into the hands of plaintiff’s attorneys, and a formerly successful major corporation (Dow Corning) was bankrupted. A moratorium was placed on the use of silicone, keeping it from patients who desperately needed it for breast cancer reconstruction. Finally, after a few decades, medical research has established beyond a reasonable doubt that the whole debacle was nonsense. Silicone is safe and finally being used again.14 What will be the result of this article? It will help sell more books for the authors and possibly help them get more grant funding, but I doubt it will result in fewer medical errors. In fact, it will likely serve only to increase already nightmarish bureaucratic burdens on medical professionals. The next time you find yourself looking at the computer terminal instead of the patient, blame inflammatory opinion
The American Journal of Medicine, Vol -, No -,
-
2016
pieces like this one. Because system errors are the most common medical errors, there will almost certainly be more cases like the Dallas Ebola case. Doctors and nurses are dedicated to improving outcomes from medical interventions, and we do not shy away from criticism. Self-serving, irresponsible sensationalism by Monday morning quarterbacks will only make the professionals’ jobs more difficult. Gerard J. Gianoli, MDa,b a
The Ear and Balance Institute Covington, La b Associate Clinical Professor Tulane University School of Medicine New Orleans, La
References 1. Makary MA, Daniel M. Medical error e the third leading cause of death in the US. BMJ. 2016;353:i21369. 2. HealthGrades Quality Study: patient safety in American hospitals. Available at: http://www.providersedge.com/ehdocs/ehr_articles/ Patient_Safety_in_American_Hospitals-2004.pdf. 2004. Accessed June 8, 2016. 3. Department of Health and Human Services. Adverse events in hospitals: national incidence among Medicare beneficiaries. Available at: http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf. 2010. Accessed June 8, 2016. 4. Classen D, Resar R, Griffin F, et al. Global “trigger tool” shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff. 2011;30:581-589. 5. Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010;363:2124-2134. 6. McCann E. Questions raised about HER workflow in Ebola case. Healthcare IT News. Available at: http://www.healthcareitnews.com/ news/ehr-flaw-core-us-ebola-outbreak. October 3, 2014. Accessed June 8, 2016. 7. Instructions for completing the cause-of-death section of the death certificate. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. Available at: http://www.cdc.gov/nchs/data/dvs/blue_form.pdf. Accessed June 8, 2016. 8. Nashellsky MB, Lawrence CH. Accuracy of cause of death determination without forensic autopsy examination. Am J Forensic Med Pathol. 2003;24:313-319. 9. Mushtaq F, Ritchie D. Do we know what people die of in the emergency department? Emerg Med J. 2005;22:718-721. 10. Mieno MN, Tanaka N, Arai T, et al. Accuracy of death certificates and assessment of factors for misclassification of the underlying cause of death. J Epidemiol. 2016;26:191-198. 11. Hoff CJB, Ratard R. Louisiana death certificate accuracy: a concern for the public’s health. J La State Med Soc. 2010;162:350-353. 12. Shojania KG, Burton EC. The vanishing nonforensic autopsy. N Engl J Med. 2008;358:873-875. 13. Trends in inpatient hospital deaths: National Discharge Survey, 2000-2010. Centers for Disease Control and Prevention. Available at: http://www.cdc. gov/nchs/products/databriefs/db118.htm. Accessed June 8, 2016. 14. Miller HI. The sad saga of silicone breast implants. Forbes. 2015. Available at: http://www.forbes.com/sites/henrymiller/2015/03/04/infuriating-titbitsabout-silicone-breast-implants/#4347e22a18d6. Accessed June 8, 2016.
Medical Error Epidemic Hysteria Medical errors are taken very seriously by our profession. This starts early in training at the Morbidity and Mortality Conference. The cases are scrutinized and criticized to see what could have been done better. No one likes to see complications or deaths, especially not physicians. So how can medical errors have become the “third leading cause of death,” as trumpeted in a recent editorial in the BMJ (formerly known as the British Medical Journal)?1 Where are those hundreds of thousands of casualties every year? The actual number of patient deaths analyzed according to the authors, over a period of approximately 10 years, was 35. I have been on 5 medical journal editorial boards and reviewed articles for 24 different journals over the past 30 years. Given what I know, I never would have agreed to have this sensationalist article published. Furthermore, the way it was reported in the general news media was irresponsible. This was NOT a scientific study at all, but only an opinion piece. It presented NO new research, it was not peer reviewed, and the studies relied on for data were not new. The article by Makary and Daniel1 simply states the average of 2 previously published studies and 2 articles that were never vetted through the peer review process, all published more than 8 years ago.2-5 All 4 of these articles include a combined analysis of a grand total of only 35 actual patients (from 2000-2008), from which the authors extrapolate to 251,454 deaths due to medical errors in the United States every year—representing 35% of all hospital deaths. This is a highly dubious estimate. On review of the 4 primary studies quoted in the BMJ article,1 I can find only 14 preventable medical error deaths (using their definition of the term), not the 35 quoted in the BMJ article. This obviously would have profound implications on the extrapolation results. No, as a peer reviewer, I would not have recommended publication of the BMJ article. As an editor, I would have at the very least sent it back asking for “major revision.”
Funding: None. Conflict of Interest: None. Authorship: The author had access to the data and played a role in writing this manuscript. Requests for reprints should be addressed to Gerard J. Gianoli, MD, The Ear and Balance Institute, 1401 Ochsner Blvd, Suite A, Covington, LA 70433. E-mail address: [email protected] 0002-9343/$ -see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjmed.2016.06.037
In research, much depends on definitions. Consider the case of someone falling from a tree. In running to catch him, you trip over a stone. The person hits the ground and dies. Did your tripping over the stone cause that person’s death or was it the fall? According to the reasoning behind the BMJ article,1 the death was your fault. No distinction is made from unintended actions and intended actions, performed well, resulting in undesired outcomes, that is, complications. When a patient was sent home from an emergency department in Dallas with Ebola last year, this was an error probably caused by electronic medical record-related disruption.6 The patient later returned and died. But he probably would have died even if this “systems” error had not occurred. The 1 case presented in the article by Makary and Daniel1 concerns a patient who died of complications from pericardiocentesis. This procedure has risks. This was not a medical error, but a known complication that can occur even when everything is done perfectly by the most competent of physicians. While proposing that iatrogenic deaths are underestimated, the authors never admit that death would be inevitable in most of these cases without medical intervention, and the margin of error in critically ill patients often is razor thin. Sadly, sometimes, even when everything is done perfectly by the best in the world, the outcome is still death. Extrapolation is a dangerous thing. Whenever one extrapolates from a study group, you must be sure that it is a “representative sample” of the group to which you are extrapolating. In this case, the authors of the BMJ article1 extrapolate from 2 studies that comprise exclusively Medicare patients and 2 studies that comprise only patients aged more than 18 years, excluding psychiatric admits, rehabilitation admits, and pediatric cases. Keep in mind that approximately 75% of all hospital deaths occur in those aged more than 65 years, and less than 6% of deaths are in those aged less than 40 years. Drew Brees is the all-time National Football League career record holder in pass completion at approximately 70%. Extrapolating from this group is similar to trying to extrapolate Drew Brees’ completion record while only using his completion success on Hail Mary passes (<5%). The extrapolation fails miserably because it is not a representative group. The BMJ article1 tries to extrapolate “medical Hail Marys” to the general medical population. This is probably why the authors of the quoted studies never extrapolated their findings to the general medical public—because it was inappropriate.
2 Makary and Daniel1 recommend changing death certificates to include a check box for “medical error death” instead of using International Classification of Diseases codes. This recommendation is misinformed because no one uses International Classification of Diseases codes on death certificates. There is a place to list “cause of death”—the physiologic reason the patient died, as well as subsequent lines for cascading events—and there is a place to list “manner of death”—homicide, suicide, accident, natural causes, and so forth. So, in essence, there already is a place to list medical error, both in the manner and cause sections.7 However, death certificates are essentially a best guess as to why someone died. If the authors of the BMJ article1 want an accurate assessment of why patients die, they should be recommending autopsies. Studies have found that 25% to 60% of death certificates are inaccurate compared with autopsy findings.8-11 Although autopsy rates were 50% in the 1970s, they have dwindled down to less than 5% currently.12 While the media is being hyped up about “increasing rates” of medical error deaths (there is no evidence that is the case), the actual total number of deaths in hospitals have been on the decline. The Centers for Disease Control and Prevention lists the number of total deaths in hospitals at 776,000 in 2000 with a slow steady decline to 715,000 in 2010.13 This decline in total hospital deaths has occurred despite increased hospital admissions in an aging population for whom the less complex surgical cases have been shifted out of hospitals to surgery centers. In other words, we are seeing substantial improvement in overall hospital mortality despite increasing complexity. The problem is getting better, not worse. The article by Makary and Daniel1 may turn out to be the “silicone breast implant hysteria” of our generation. In the 1980s and 1990s, there was much hype about silicone breast implants causing an epidemic of medical ills. The hysteria surrounding this was fueled by the Food and Drug Administration, the media, and the plaintiff’s attorneys. As a result, many implants were removed without medical justification, undeserved money went into the hands of plaintiff’s attorneys, and a formerly successful major corporation (Dow Corning) was bankrupted. A moratorium was placed on the use of silicone, keeping it from patients who desperately needed it for breast cancer reconstruction. Finally, after a few decades, medical research has established beyond a reasonable doubt that the whole debacle was nonsense. Silicone is safe and finally being used again.14 What will be the result of this article? It will help sell more books for the authors and possibly help them get more grant funding, but I doubt it will result in fewer medical errors. In fact, it will likely serve only to increase already nightmarish bureaucratic burdens on medical professionals. The next time you find yourself looking at the computer terminal instead of the patient, blame inflammatory opinion
The American Journal of Medicine, Vol -, No -,
-
2016
pieces like this one. Because system errors are the most common medical errors, there will almost certainly be more cases like the Dallas Ebola case. Doctors and nurses are dedicated to improving outcomes from medical interventions, and we do not shy away from criticism. Self-serving, irresponsible sensationalism by Monday morning quarterbacks will only make the professionals’ jobs more difficult. Gerard J. Gianoli, MDa,b a
The Ear and Balance Institute Covington, La b Associate Clinical Professor Tulane University School of Medicine New Orleans, La
References 1. Makary MA, Daniel M. Medical error e the third leading cause of death in the US. BMJ. 2016;353:i21369. 2. HealthGrades Quality Study: patient safety in American hospitals. Available at: http://www.providersedge.com/ehdocs/ehr_articles/ Patient_Safety_in_American_Hospitals-2004.pdf. 2004. Accessed June 8, 2016. 3. Department of Health and Human Services. Adverse events in hospitals: national incidence among Medicare beneficiaries. Available at: http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf. 2010. Accessed June 8, 2016. 4. Classen D, Resar R, Griffin F, et al. Global “trigger tool” shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff. 2011;30:581-589. 5. Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010;363:2124-2134. 6. McCann E. Questions raised about HER workflow in Ebola case. Healthcare IT News. Available at: http://www.healthcareitnews.com/ news/ehr-flaw-core-us-ebola-outbreak. October 3, 2014. Accessed June 8, 2016. 7. Instructions for completing the cause-of-death section of the death certificate. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. Available at: http://www.cdc.gov/nchs/data/dvs/blue_form.pdf. Accessed June 8, 2016. 8. Nashellsky MB, Lawrence CH. Accuracy of cause of death determination without forensic autopsy examination. Am J Forensic Med Pathol. 2003;24:313-319. 9. Mushtaq F, Ritchie D. Do we know what people die of in the emergency department? Emerg Med J. 2005;22:718-721. 10. Mieno MN, Tanaka N, Arai T, et al. Accuracy of death certificates and assessment of factors for misclassification of the underlying cause of death. J Epidemiol. 2016;26:191-198. 11. Hoff CJB, Ratard R. Louisiana death certificate accuracy: a concern for the public’s health. J La State Med Soc. 2010;162:350-353. 12. Shojania KG, Burton EC. The vanishing nonforensic autopsy. N Engl J Med. 2008;358:873-875. 13. Trends in inpatient hospital deaths: National Discharge Survey, 2000-2010. Centers for Disease Control and Prevention. Available at: http://www.cdc. gov/nchs/products/databriefs/db118.htm. Accessed June 8, 2016. 14. Miller HI. The sad saga of silicone breast implants. Forbes. 2015. Available at: http://www.forbes.com/sites/henrymiller/2015/03/04/infuriating-titbitsabout-silicone-breast-implants/#4347e22a18d6. Accessed June 8, 2016.