Tuesday, October 29, 2013

Errors in Medical Treatment

Medical care is simple in theory, but complex in execution due to additional difficulty factors associated with human behavior, thorough record keeping and bureaucratic overview that go beyond diagnosis and treatment. Therefore, while most lay individuals were surprised when the Institute of Medicine (IOM) estimated an annual death total between 49,000 and 98,000 stemming from medical errors, most individuals with experience in the field were saddened, but not surprised.1 After the IOM issued the estimate in “To Err is Human: Building a Safer Health System” the medical community was initially galvanized ready to act to correct these unnecessary deaths developed through miscommunication, inefficiency and/or neglect.

Early results from this resolve demonstrated positive results such as a reduction in deaths from accidental injections of potassium chloride, lower rates of hospital-born non-MRSA infections, fewer warfarin derived complications in addition to the Institute for Healthcare Improvement’s (IHI) 100,000 Lives Campaign and companion 5 million Lives Campaign.2-5 However, a number of individuals believe that these successes are marginal for other negligent hospital/physician actions have increased in addition to those who believe that the initial IOM figure was underestimated.6-9 Overall within the environment where various groups “duke it out” over whether or not medical care has become safer from a patient perspective over the last two decades, the real questions are how can safety be improved and why are these ideas not being implemented as effectively as theory suggests.

One of the chief concerns with actually accurately identifying negative instances or preventable adverse events (PAEs) at hospitals and/or under physician care is the issue of various conclusions amid a feedback environment. Basically regardless of what side one takes on the issue of PAEs and their prevalence that individual can find valid evidence to support his/her position. Therefore, individuals who want to believe that PAEs have increased will principally cite evidence that suggests this reality whereas individuals who believe that PAEs have decreased will principally cite evidence of such a reduction. This researcher behavior creates a feedback environment were neither side will gain much ground because each side is simply reinforcing their own bias. Note that according to the IOM a PAE is defined as an “unintended harm to the patient by act of commission or omission rather than by underlying disease or condition of the patient”.

Part of the reasoning behind why such a contrasting reality can exist is that calculated PAEs can either go up or down depending on the type of boundary conditions and assumptions an investigator applies. For example what element is important when considering PAEs in hospital settings? Should the goal be to lessen the severity of the event (reduce the probability of death), lessen the number of events period, record all occurred events, how much should a patient’s health be compromised before it qualifies as a PAE, etc.? Without clearly identifying the expectations of the study and correcting for the goals of the hospital with relation to PAEs little useful knowledge can be gleamed from these numerous studies about PAEs in hospitals.

Another issue is the separation of responsibility between physician and patent. Rarely does research that concludes an increase in PAEs differentiate fault for particular PAEs between physicians and patients. For these researchers the entirety of the fault for any PAE is placed upon the physician. This mindset is an interesting one and seems to apply a negative bias against physicians (NBAP), which can be highlighted by the following analogy.

Currently in 2013 there are numerous reality television shows that involve a specialist of sorts intervening in a failing business and changing various elements in an attempt to make it a success. Two particular “hosts” have dramatically different mindsets when it comes to the structural operational methodology of business. In the show “Bar Rescue” Jon Taffer believes that while management leadership, direction and training are important, individuals have pride, self-respect, honor and intelligence and even in situations where training and leadership is lacking should be expected to act in a certain manner and perform their job with some level of competency, honesty and dignity. In contrast “Restaurant Stakeout” host Willie Degel seems to believe the opposite, that management and training are the foundation of praise or blame regarding job performance. Basically Mr. Degel seems to believe that employees are sheep without any ethics, ambition or pride, thus if the proper training is not provided it should be expected that these individuals will fail miserably at their jobs.

The mindset of Mr. Degel mimics the one possessed by most NBAP researchers where the physician is responsible for all mistakes regardless of the behavior or actions of the patient. For example suppose a patient suffers from an episode of respiratory distress during aerobic activity. After visiting the hospital resultant tests fail to find any obvious underlying causes for the episode. Clearly it is not entirely the responsibility of the physician to inform the patient not to engage in aerobic activities in the near future. The patient has to have some understanding that without a clear diagnosis future aerobic activities must be undertaken with significant caution and care otherwise an even more detrimental condition may arise. If the patient forgoes this common sense understanding and befalls a more detrimental condition, it should not be regarded as the fault of the physician. Similar blame elements would involve patients not telling physicians about certain allergies or other utilized medications that lead to complications brought on by negative reactions between the old medication/allergy and the new medication.

High quality medical care is a partnership between the physician, the hospital and the patent; for those who want to reduce/eliminate medical errors it is necessary to differentiate between errors caused by patents and those caused by physicians/hospitals. This differentiation must not be sought with the intention of assigning responsibility, but to properly assign responsibilities to all parties to maximize the probability of eliminating errors. Individuals who refuse to identify events where patient behavior increased the probability of an eventual PAE are doing a disservice to the goal of eliminating medical errors.

Even if individuals differentiate between patient and physician/hospital fault when attempting to determine the cause behind certain PAEs it is irrational to expect all PAEs to be eliminated due to the simple fact that mistakes will always happen. The general mindset should be to limit the severity of PAEs as much as possible. For example if the PAE magnitude is converted from 1000 harms with 100 deaths to 1043 harms with 50 deaths such a change can be considered a short-term victory with more improvement desired in the future.

Some investigators believe that there are numerous unreported PAEs and justify this belief through the use of the discrepancy between PAEs reported in outpatient surveys and official medical reports.10 Weissman and colleagues found that 6 to 12 months after their discharge, patients could recall 3 times as many serious PAEs as were reflected in their medical records. Unfortunately there are some concerns with this study. First, there is no clear understanding that patients and physicians/hospitals have a similar definition for a PAE, which could result in patients overestimating the number of PAEs during their treatment. For example failure to give a certain medication at a certain time could technically be regarded as a medical error, but if said medication is given within a given time boundary beyond that specific time no harm should befall the patient. So while such an event could be regarded as an error, it is not a PAE.

Second, patients may regard elements or instances of discomfort through their own personal lens as a PAE. For example a patient may want a glass of water, but due to nurse/physician preoccupation in other more pressing tasks this individual waits a long time before getting the water and possibly develop a slight case of dehydration while waiting. For the patient such an event could easily be a PAE, but from the perspective of the hospital such an event is irrelevant. Third, patients are not aware of a significant amount of “behind the scenes” actions relative to their treatment, thus have incomplete information regarding overall treatments and may mischaracterize certain outcomes as PAEs.

Most individuals classify PAEs into four separate categories:

- Diagnostic Errors
- Communication Errors
- Omission Errors
- Commission Errors

Diagnostic errors are rather self-explanatory, but are also the trickiest of the four categories when attempting to deduce between honest or negligent mistakes. If one could have all possible information available through various diagnostic tests (MRI, CT, PET, etc.), a full accurate medical history and a patient with a photographic memory who did not withhold information then it could be determined that all diagnostic errors were the fault of the physician either due to lack of knowledge or negligence. Unfortunately never are these environments of complete information available; therefore one must judge diagnostic errors within effective probability matrices. For example if patent A presents with a list of symptoms that suggest a 74.1% probability that condition A is the cause, which has a low probability of significant damage versus a 4.6% probability that condition B is the cause, which has a high probability of significant health damage and the physician treats for A instead of B, even if B turns out to be correct the physician should not be viewed at fault.

Communication errors are commonly defined by misinformation between two interacting parties resulting in a negative health occurrence. Normally communication errors stem from incomplete or inaccurate patient information due illegible writing leading to confusion between drug prescriptions, disconnected or fragmented reporting systems and/or inconsistent or repetitive care due to numerous physician interactions. Lack of patient background and disclosure can also be viewed as communication errors originating with the patient. Most believe that the adoption of electronic health records (EHRs) will reduce a significant percentage of the communication errors by creating a redundant system of error checking. More than likely this assertion is correct; however, implementation and proper use of HER in hospitals nationwide is still problematic and slow.

Commission errors are the easiest error to detect after the fact for it involves a physician or hospital taking a form of negligent action: either the wrong methodological action or a right action executed improperly that results in harm to the patient. The most common publicized commission errors seem to be surgical mistakes where foreign objects are left in patients, incorrect procedures are carried out (amputating the wrong limb is a noteworthy one) or accidentally damaging a part of the body (nicking a blood vessel when conducting a heart bypass, etc.). Fortunately commission errors can be managed because most occur due to carelessness born more not from physician incompetence, but other environmental factors like time pressures, fatigue, short-term psychological stress and/or too any patients.

Omission errors typically contrast commission errors, where an obvious action was required for treatment, but was not executed; similar to commission errors, omission errors can be easily detected after looking at properly compiled medical records. The most common omission errors involve the lack of drug administration to augment a specific treatment like an alpha- or beta-blockers for certain heart procedures.

One of the biggest issues regarding medical errors is the physician culture. In the past the physician was largely regarded as a position of great respect held by learned individuals. Compound this element with the fact that most physicians hyperbolize the capacity of their position “commanding” life and death, the ego and stress related to the position with regards to being “perfect” is further augmented. When a physician makes a mistake those who are not complete assholes or in denial take direct damage to their self-image and may attempt to hide the error behind a wall of cognitive dissidence in order to maintain the “perfect” persona. Public acknowledgment of the error limits the effectiveness of this cognitive dissidence strategy, thus could further increases the desire to hide the error. Therefore, for a number of physicians lawsuits may be of secondary concern versus potential psychological damage. This shame factor would probably explain most of the “hidden” errors that many NBAPs claim exist.

Unfortunately modern times have only applied more pressure to this “perfect” persona, especially due to the rise of the Internet. Now vast amounts of patients “research” potential causes for their medical conditions on broad kitchen sink websites like WebMD and make suggestions or even challenge diagnostic conclusions made by physicians damaging their authoritative specialization. The most problematic element of introducing this “research” into the diagnostic equation is that most patients will credit a much higher than rational occurrence probability for lethal or seriously detrimental conditions. Worse yet this unsubstantiated fear will be utilized as blame and legal ammunition on the extremely small probability that the cause of said condition was actually a low probability condition and the physician did not prescribe every possible test, regardless of cost and stress to the patient, to deduce it. Such a probability irrational environment adds even more pressure to physicians.

Now some cynics may simply state that physicians need to drop the narcissus act and man/women up. Outside of the simple retort that such a “solution” can be levied against numerous problems in various occupations, the problem with this belief is that physician training encourages this narcissus attitude out of belief necessity with a little ego of status. With regards to belief necessity what patient wants an indecisive physician? Physicians need to exhibit confidence, even on the borderline of arrogance (especially surgeons), to assure patients that they have a high probability of certainty regarding the type of ailment and the treatment protocol. Of course the ego element comes from the notoriety of the position in society despite its erosion in recent decades in part due to the Internet. Overall it can be argued that change is needed, but it would be more useful for cynics to offer a psychological means to drive that change rather than simply state that change should happen.

Another concern is the perception of medical mistakes. As stated above due to authority and prestige issues most physicians, especially specialists, become perfectionists out of medical school. This characterization creates a black-and-white mindset where physicians are either perfect or terrible, which is reinforced by morbidity and mortality review boards. A single mistake, whether understandable or not, can result in a “killer”, “007” or some other “clever” characterization for a physician. Most NBAPs say they could forgive an “honest” mistake, but a vast majority of those who say this have never been on the receiving end of these types of mistakes, so with their inherent bias towards physicians already would this proclamation hold true actually when tested?

Unfortunately some have attempted to adjust these review boards by making them more team centered. However, this strategy seems to be in error because while the motto “We win as a team we lose as a team” may work for sports it does not work in medicine. Such a strategy creates an unrealistic micromanage mentality for the “leaders” of these medical teams due to the level of work that is required. It also mitigates the responsibility of the error, which could reduce the shame individually associated with it, but will also reduce the probability that the individual learns from and corrects the behavior that created the error in the first place. Instead the boards should be teaching environments where blame is not shamed nor avoided, but identified and corrected. Pursuant to a significant error individual actions within the appropriate acting team should be identified to determine where the error occurred, what type of error it was and why it occurred. Medical personnel will also be penalized through a clear transparent evaluation system, which will eventually result in job termination if enough mistakes are made.

One of the major concerns with physician training is that some believe the process of becoming physicians erodes empathy from medical students even though they enter medical school with plenty. Part of the rationality is that the third and fourth years, which are clinical, are disjointed and emasculating due to constant testing and relocation fostering an attitude of “just another cog in the machine”. Another aspect of training that enhances this mindset is its monotonous nature with each sleep-deprived day bleeding into the next.

However, empathy is a two-way street. While a number of physicians have problems properly exhibiting it, if they have it at all, patients also fail to appreciate what physicians have to deal with in an average day. From the patient’s mindset he/she only cares about getting attention and an effective analysis and conclusion regarding diagnostic and treatment. He does not care that the physician has patients other than him, who expect the same, and other tasks that need to be completed beyond his medical treatment. Certainly one can somewhat understand this mindset as patient attitude can range from frustration due to being sick to panic due to the potential for having a serious medical condition, but empathizing with this attitude is no excuse for the hypocritical reasoning of criticizing lack of empathy in physicians, but ignoring it in patients.

One way to potentially manage the empathy erosion that occurs in medical school is to breakup the process itself. In most medical school training the first two years involve classroom and lab study with the second two years involving medical training and residency. This process should be adjusted. In a new system the first year would involve basic medical training. Remember that almost all medical students are “pre-med” so they have rudimentary medical knowledge about biology and chemistry, thus this first year should not be review, but involve new medical training and procedure information. In the second year students would enter a clinical environment to apply their knowledge and get a feel for their occupational requirements. The third year would involve returning to the classroom to acquire more advanced medical techniques, organization skills and logistics, and psychological coping techniques. Introducing these advanced techniques after exposure to a clinical environment will increase the probability that medical students appreciate their importance and can better incorporate them into their behavior. The final year would involve selecting a specialization (or general practice) and tailoring their clinical experience towards this specialization to lead into residency.

A further concern with the education structure for physicians is the lack of a well integrated and effective occupational education system. Basically after a physician graduates from medical school and residency it is “assumed” that physicians possess all requisite knowledge for the remainder of their medical careers. Of course such an assumption is wrong, especially when dealing with technology, so why are there not small periods of time where physicians are required to update their skill sets (similar to a sabbatical). Some would argue that due to general physician shortages (especially at the general practitioner level) there is little ability to develop effective downtime to acquire new skills or update existing ones. Regrettably this is a relevant retort and add to that concern that an additional 35 to 50 million uninsured individuals with at least 15 million having chronic and/or pre-existing conditions have now or will soon acquire health insurance finding time for physicians to skill enhance becomes even more difficult. Unfortunately there may not be an effective solution to this issue beyond simply creating more physicians and hospitals may have to augment physicians with hired secondary help for specific technological skills.

Numerous suggestions in the past through various communication mediums have been made regarding how to reduce the probability of medical errors and below will be no exception. Clearly one of the most obvious strategies is to create checklists for each type of medical procedure and diagnostic exam ensuring that proper methodologies are followed, which will heavily reduce the probability of any stupid careless mistakes. An additional easily applicable safety measure is redundant question asking among physicians, nurses and pharmacists to patients to confirm unanimous agreement regarding action among relevant parties. Clearly the introduction of electronics from physician order entry (POE) for prescriptions to EHR will reduce transcription and medication assignment, cross-reaction and dosage errors. Finally creating better ways for physicians to manage fatigue through efficient on-call rotations and nutrition/diet recommendations should reduce errors.

Another issue with correcting medical errors can come from addressing the “perfection” mindset by creating a more transparent legal avenue for redress steaming from negligent behavior. Part of the problem is that some individuals who experience a PAE in a hospital feel that it is their right to receive some monetary compensation for their negative experience; a sincere apology will not be sufficient. Some have attempted to address this “sue-happy” litigation culture through the use of monetary malpractice caps, but this response is not structured properly because the ceiling is universally blind; it does not appreciate that certain medical errors impact an individual both physically and psychologically in different ways and more severely than others.

To better address the issue of medical errors and their proper disclosure one has to focus on the environment of perfection and fear. Beyond the perfectionist characteristics of physicians there is some natural fear as well when interacting with patients that have experienced a PAE. The first element that drives this fear is the natural aversion most individuals have to confronting angry individuals when it is suspected that the anger will be justifiably directed at them. The second is that admitting to the mistake will open the door for a lawsuit through the general admission of guilt when discussing the error. This lawsuit would then result in potential lost employment and increased malpractice insurance premiums. This aspect of the fear is the driving force behind the common “deny and defend” strategy utilized by hospitals in response to lawsuits. Finally due to the “deny and defend” and “sue-happy” environments an inherent adversarial relationship has developed between lawyers and physicians.

A cap limit on medical malpractice claims is not the only legal reform attempted to ease the difficulties between patient and physician interaction after an error. Thirty-six states have passed “apology laws”, which limit the admissibility of physician statements of a sympathetic nature in a civil lawsuit regarding the incident for which the statements were made.11

One theoretical success of apology laws is that it allows honest communication between patient and physician. For example one study determined that one of the primary factors behind attorney acquisition is patient frustration born from a lack of adequate answers to their questions about significant negative experiences during a hospital visit.12 Some even think that they are helping future patients by demonstrating to the hospital/physicians that there are consequences to an avoidance and denial strategy. For these patients an honest and clear explanation along with an apology would have eliminated the need to seek the services of outside council.

The overall results of whether or not more disclosure catalyzed by apology laws would increase or decrease total liability remains mixed. Some risk managers still feel that while specific statements will be excluded due to apology law, the admission itself still confirms that the hospital/physician made an error opening the door for a lawsuit13-15 However, other studies have demonstrated that within certain operational parameters that a disclosure program can be successful without increasing liability claims or costs.11,16

So what should be the proper procedure when a medical error is discovered:

1. Unless the medical error is one of life-threatening immediacy the medical team treating the individual should be gathered and informed of the medical error with instruction regarding how it will influence current and future treatment. The gathering should not occur immediately after the error is discovered (due to the potential for other ongoing obligations), but should occur in a timely fashion. Immediately after coming to the necessary conclusions regarding future actions, those actions should be executed.

2. Assign an individual to officially document the medical error and report it to the appropriate authoritative body. In addition add the information to the patient’s official medical records so future healthcare providers are aware of its occurrence so it can be utilized later in potential future diagnostics.

3. Inform the patient and any potential medical proxies about the error itself, why it occurred, how it occurred and what future steps are now recommended because of the error. Inform the patient and appropriate parties of their role, responsibilities and rights in addressing the reporting of the error. Finally sincerely apologize for the error and communicate what type of consequence was applied to the offending party.

4. During the next medical and mortality board all recorded medical errors are reviewed with the intent to explain to all other parties what the error was, why it occurred and what actions were taken after the mistake was identified. There is no need to identify the responsible parties behind the mistake because responsible parties have already been brief on the mistake and its consequence to their careers in the above earlier meeting. Due to this previous briefing there is little reason to officially “introduce” the individuals behind the error to the rest of the hospital for the general purpose of ridicule.

The advantages of such a system for addressing medical errors are numerous: 1) the patient receives prompt information regarding their current situation, transparent facts about the reasons behind any errors and consequence to the responsible party; 2) all relevant hospital staff are informed of the error and instructed to learn from it without direct reputation consequence to the offending party (whether or not staff hear something through the “grapevine” is uncontrollable); 3) the error is addressed openly, thus reducing the probability of escalating any detrimental condition derived from the error because corrective treatment will begin much quicker;

While there is still robust debate about how many individuals unfortunately lose their lives in hospital settings due to some significant form of medical error, the response to these events should be the same because a large number are born from negligence either on the side of the patient or the physician/hospital. There is large agreement regarding what needs to be done, but both meaningful and superficial obstacles remain in the way. Meaningful obstacles involve the incorporation and proper use of technology, getting patients and insurance companies to buy into the advantages of evidence-based medicine and creating effective networks between medical institutions and home life for various patients. Superficial obstacles are largely psychological and cultural between both patients and society regarding egos and expectations. Much to the chagrin of some individuals, the expectation for private driven compliance and evolution of medical safety in hospitals is short-sighted due to a lack of motivation; therefore, the intervention of penalties and an organized central entity should be encouraged to catalyze the administration of safety procedures in medical institutions.

Citations –

1. Kohn, K, et Al. “To Err is Human: Building a safer health system.” Washington D.C.: National Academy Press. 1999.

2. Joint Commission on Accreditation of Healthcare Organization. Sentinel event trends: potassium chloride events by year.

3. Kelly, J, et Al. “Patient Safety Awards: safety, effectiveness, and efficiency: a Web-based virtual anticoagulation clinic.” Jt Comm J Qual Saf. 2003. 29:646-651.

4. Whittington, J, and Cohen, H. “OSF Healthcare’s journey in patient safety.” Qual Manag Health Care. 2004. 13:53-59.

5. Leape, L, and Berwick, D. “Five years after ‘To Err is Human’ What have we learned?” JAMA. 2005;293:2384-2390.

6. James, J. “A new, evidence-based estimate of patient harms associated with hospital care.” Journal of Patient Safety. 2013. 9(3):122-128.

7. Landrigan, C, et Al. “Temporal trends in rates of patient harm resulting from medical care.” N Engl J Med. 2010. 363:2124Y2134.

8. Hayward, R, and Hofer, T. “Estimating hospital deaths due to medical errors.” JAMA. 2001. 286:415Y420.

9. Brennan, T, et Al. “Incidence of adverse events and negligence in hospital patients: results of the Harvard Medical Practice Study.” N Engl J Med. 1991. 324:370Y376.

10. Weismann, J, et Al. “Comparing patient-reported hospital adverse events with medical records reviews: Do patients know something that hospitals do not?” Ann Intern Med. 2008. 149:100Y108.

11. Kachalia, A, et Al. “Liability claims and costs before and after implementation of a medical error disclosure program.” Ann Intern Med. 2010;153:213-221.

12. Vincent, C, et Al. “Why Do People Sue Doctors? A Study of Patients and Relatives
Taking Legal Action.” Lancet. 1994. 343:1609-1613.

13. Butcher, L. “Lawyers say ‘sorry’ may sink you in court.” Physician Exec. 2006. 32:20-4.

14. Kachalia, A, et Al. “Does full disclosure of medical errors affect malpractice liability? The jury is still out.” Jt Comm J Qual Saf. 2003. 29:503-11.

15. Studdert, D, et Al. “Disclosure of medical injury to patients: an improbable risk management strategy.” Health Aff (Millwood). 2007. 26:215-26.

16. Boothman, R, et Al. “A better approach to medical malpractice claims? The University of Michigan experience.” J. Health and Life Sci. 2009. 2(2):125-159.

No comments:

Post a Comment