The Standard of Care: Medical Errors/Violations and the Law

A medical negligence case is the result of a clinical situation that has had an adverse outcome alleged to be due to a medical error or rule violation. The task of the medical expert is to determine what actions a defendant physician should have taken, or not taken, and whether a breach of duty has occurred, in accordance with the parameters set forth by the standard of care. Thus, the medical expert must understand elements of the standard of care and determine whether that standard was met. This article explains why understanding the standard of care can be challenging.

Defining the Standard of Disclosure

Two dominant approaches, the “professional” standard and the “materiality” standard, define the standard of disclosure of information by which a physician’s duty to the patient is measured.(1) The professional standard requires the physician to disclose information that other physicians possessing the same skills and practicing in the same or a similar community disclose in a similar situation.(2) The second approach is the “materiality” or “prudent patient” approach, allowing the jury to decide whether other information would have been considered important by a reasonable patient in making a decision, therefore requiring disclosure.(3)

The courts recognize situations when a physician’s nondisclosure will be excused, including cases of the patient’s mental incompetence, medical emergencies, and the therapeutic privilege exception.(4) If a patient is incompetent to make a reasoned decision, then disclosure to the patient might not be required.(5) The physician can also withhold information under the therapeutic privilege if disclosure would interfere with treatment, or would adversely affect the condition or recovery of the patient.(6) The emergency exception to disclosure applies in situations where attempting to secure consent would delay necessary and proper treatment.(7) Last, physicians need not disclose risks of which the patient is already aware, or risks that are commonly known.(8) Individual state law and court decisions determine which approaches and exceptions apply in an individual physician’s practice (Table 1).

Physician’s Duty to Disclose Risk Information

“Materiality” jurisdiction courts have attempted to provide some guidance for physicians by suggesting that the physician’s duty to disclose risk increases as the magnitude of the risk increases. These courts uniformly fail to give explicit guidelines or to identify on what scale risks are to be measured.(9) All severe risks (e.g., death, paralysis, loss of cognition, loss of a limb) should always be disclosed, even if the probability of occurrence is negligible. Further, even less severe risks, if they occur frequently, should always be disclosed. Nominal risks with low probability of occurrence need not be disclosed. Courts do not place emphasis solely on consequences, recognizing frequency as an important component of risk.(10) The “professional” standard asserts that the doctor’s duty to disclose is what a reasonably prudent physician with the same background, training, and experience would have disclosed to the patient in the same or similar circumstances. The professional standard does not give explicit guidelines regarding the disclosure of risks, but would be established by medical expert testimony.

The courts stress that full disclosure is not required. Full disclosure is a slippery slope for physicians involved in medical informed consent. There are reasons why full disclosures, as a standard of practice, should not be expected. First, the number of risks possible from even a routine procedure is large, and potential risks can span a range of consequences. For example, in a footnote, the California Supreme Court listed some of the risks of having blood drawn: “[T]he risks . . . are said to include hematoma, dermatitis, cellulitis, abscess, osteomyelitis, and death, to mention a few.”(11) Second, the burden of identifying small consequences in extremely unlikely risks is too great a burden on the physician, and the resulting choice by the patient will be impaired by a litany of consequences. Despite the courts’ pronouncements that full disclosure is not required, they have failed to delineate any clear limits on what must be disclosed. The California Supreme Court articulated this uncertainty: “One cannot know with certainty which medical consent is valid until a lawsuit is filed and resolved.”(12) There does not appear to be a standard of disclosure to which physicians can adhere to avoid liability with any certainty (Table 1).

The Standard of Care Remains Obscure

Clinical experiences and review of expert witness testimony suggest that a complete understanding of the standard of care is still ambiguous. What is a “standard of care”? Who determines the prevailing standard of care? This article examines these questions, beginning with an overview of the history of the standard of care and using case law to trace its evolution from a local standard to a national standard. We probe the waning of the locality rule and consider the entry of national standards of care. Finally, we address the relationship between the standard of care and concepts with which it is often conflated, such as best practices, expert opinions, and the now pervasive clinical practice guidelines.

Conceptual Underpinnings of “Standard of Care”

The “standard of care” is best perceived as a fluid and changing standard by which the law measures liability. The moral climate against which it is defined dictates that the prevailing standard should be viewed as what can be reasonably expected of people. The standard is embedded in the language of culpable failure. Culpable failure implies responsibility and the deserving of blame for having done something wrong. Often, in summation, the question before the court is whether the conduct of the actor being considered is below the standard that can be expected by the plaintiff in the circumstances in question, and that expectation is different for professionals as opposed to laypeople. Ultimately, the law imposes civil liability in those cases where the defendant risked unacceptable harm, whether or not he or she intended to place others at risk, and whether or not she was capable of acting to a higher standard. The court at such a level defines the standard that most people in the profession might reasonably meet it. The standard is pegged to a sense of the possible and reasonable.

A standard of care must rest on an understanding of reasonableness and foreseeability, and overcome the inherent biases of hindsight and outcome.

The principal judicial foundation for the attribution of liability includes a consideration of justice and equity. A standard of care must galvanize an understanding of reasonableness and foreseeability, and overcome the inherent biases of hindsight and outcome. It is easy today to say the Challenger space shuttle should not have been launched, because we know in hindsight that the O-rings failed. This is the wisdom of hindsight, wisdom that often compels the reviewer to conclude that we should have seen a disaster coming, even if those who acted did not foresee it. Outcome blame causes us to attribute blame more readily with a seriously adverse outcome than when the outcome is comparatively minor. The significance of outcome bias is that if the harm is great (e.g., death), the desire to find wrongdoing is intense, whereas if evaluated dispassionately, there may be no negligence found. The variables of reasonableness, foreseeability, hindsight, and outcome bias must be inserted into the calculation that defines our standard of care.

The Human Factor—Understanding Errors, Violations, and Recklessness

Misfortune invites explanation. When things go wrong in human affairs, the inevitable response is to seek an explanation for the mishap. Human curiosity compels us to try to understand the events that touch our lives and the lives of our loved ones. Mishaps in medicine are no different, and when there is a tragic outcome, the search for an answer may become all consuming. This mandates a discussion and understanding of human errors, violations, and acts of malice in relation to the standard of care. When we are evaluating events for the purpose of attributing blame we must focus on the actions and thought processes, not on the results or outcome. This makes it important for us to define errors, violations and acts of malice.

Reason(13) defines error as an unintended failure in the formulation of a plan intended to achieve a goal, or an unintentional departure of a sequence of mental or physical activities from the sequence planned.

This definition retains the principle that errors are not associated with automatic actions, and that there must be some intended aspect of the act or plan that goes awry. The error itself is unintentional; the error shifts focus from the outcome of an act to a failure in the act or plan itself. There are skill-based, rule-based, and knowledge-based errors. It is imperative to understand the distinctions among these types of errors and how they relate to attribution of fault.

• Skill-based errors involve actions and usually are the result of distraction. Human are prone to distraction. For example, the distribution of medication to the wrong patient often results from a lapse in attentiveness to the task at hand.

• Rule-based and knowledge-based errors are problem-solving failures or planning failures and are grouped under the heading of mistakes. Rule-based errors involve some failure in the process by which a set of circumstances is recognized and an appropriate rule is applied. In medicine, physicians use a mental schema called frequency gambling. Physicians tend to choose an algorithm known to have worked on previous occasions in similar circumstances without establishing beyond a doubt that the clinical situation is equivalent. The problems that evolve from a rule-based approach are that the rule selected may be inadequate or it may simply be wrong.(13)

• Additionally, in medical practice we may have technical errors and errors in judgment. Technical errors are a type of skill-based error distinct from lapses. In technical errors there is a failure to carry out the intended procedure successfully. This may be related to patient variability, or variation in the skill and knowledge of the practitioner. Technical errors are an important category of error in medical practice, because specialists are being called upon to do increasingly difficult and hazardous procedures on sicker and sicker patients.(14) These errors may be an inherent risk of the procedure that require disclosure.

Trial-and-error deliberation (i.e., thoughtful due diligence to the issues inherent to the treatment/procedure) is a slow, planned process of reasoning with constant feedback. This is a powerful, but slow, tool. There must be adequate time, and it is only reasonable if a trial-and-error approach can be tolerated. Because it is an error driven process, it follows that deliberative reasoning will be inevitably prone to errors, especially at an early stage of the iterative process. The implications of this for a medical emergency are obvious. The common allegation physicians face is an error in judgment, which falls into the category of an error in deliberation.(13)

The element of choice in relation to an action, but not related to the outcome, defines an action, which, falling short of some identifiable standard, is a violation, rather than an error. A violation is a deliberate—but not necessarily culpable—deviation from those practices appreciated by the individual as being required by regulation, or necessary, or advisable to achieve an appropriate objective, while maintaining the safety of patients and the ongoing operation.(13)

Violations are defined in relation to established rules. The existence of the rule makes the violation crystal clear. The rule need not be formalized in writing; it is enough to know some identifiable rule has been knowingly breached. This principle may involve foreseeability or variation from scientific fact. Take the case of the surgeon who goes from room to room without washing hands in between examining different patients. The well-established rule being violated is that hand washing between examining patients reduces the risk of infection.

The fact that a course of action constitutes a violation does not necessarily mean that it amounts to recklessness. Recklessness carries a considerable amount of moral opprobrium. Recklessness implies knowing that an action or omission will involve an unacceptable level of risk to someone, and deciding nevertheless to take that risk. Violations involve a decision to do something with the knowledge that the given action or decision will place at risk some aspect of safety.

Writing in The New Yorker, Atul Gawande observed that “The real problem isn’t how to stop bad doctors from harming, even killing their patients. It’s how to prevent good doctors from doing so.”(15) In 1984, the Libby Zion case highlighted the role fatigue was playing in medical errors and violations.(16) The natural inference is that a good physician who is fatigued will be prone to medical errors and violations.

The commission of a violation is a clear wrong in respect to the rights of those affected. We have distinguished errors that should be accepted as an inevitable consequence of complex human undertakings; the same does not necessarily apply to violations. It is complicated because certain necessary violations (e.g., meeting a workload that results in fatigue) may be imposed upon the practitioner by the system. The gray area surrounding definitions of medical errors, violations, and reckless behavior must be appreciated to perceive the complexity of assigning blame when there is alleged negligence. The standard of care must reflect the threshold where medical errors and violations will invoke the charge of negligence.

From Theory to Real-World Negligence

What is medical negligence? Medical negligence is an act, or omission, by a medical professional that deviates from the accepted medical standard of care. This begs the question: what is the standard of care? Standard of care refers to the degree of attentiveness, caution, and prudence that a reasonable physician in the existing circumstances would exercise. Failure to meet the standard is negligence, and the person who fails to meet the standard is liable for any damages caused by such negligence. The relation between the standard of care and negligence is similar to a lock and key “fit” that opens the door.(17)

In medical negligence cases, the medical expert must explain to a trier of fact what a defendant physician should have done, or not done, in a specific set of circumstances, and whether the physician’s conduct constitutes a breach of duty. The parameters of that duty are delineated by the standard of care. Many facets of the standard of care have been well explored in the literature, but gaps remain in establishing a wide-ranging understanding of this concept.

The standard of care changes through time. We examine those changes and adaptations in the understanding of the standard of care, including the locality rule and the now well-recognized national standard of care. The locality rule required a defendant physician to provide the same degree of skill and care that is required of a physician practicing in the same or similar community. This rule remains alive in a few jurisdictions in the United States, but the locality rule has been largely abandoned in favor of a national standard of care. This has been justified by the fact that the impact of telecommunications allows physicians equal access to information. Lastly, we address the relationship between the standard of care and clinical practice guidelines.

The Locality Rule

As malpractice law evolved, courts began comparing a physician’s practice with those of similarly situated physicians in their community. The applicable standard of care in medical malpractice lawsuits varies somewhat among jurisdictions in the United States. The locality rule requires defendant physicians to provide the same degree of skill and care that is required of other doctors practicing in the same or similar community. It places a geographical dimension on the professional standard of care in medical negligence litigation.(18) The strictest form of the locality rule would require expert witnesses to practice in the same or a similar community of the case in which they are offering opinions.(19) Once widely adopted in the United States, the locality rule was originally designed to protect rural physicians from having to uphold the same standard of care as that provided in the academic health science centers and modern clinics of the city.(20) It was believed that rural practitioners lacked equipment comparable to that of urban health centers and did not benefit from the latest advances in science and practice that emanated from medical research conducted at urban hospitals. The origin of the locality rule is often attributed to Small v. Howard.(21)

The Supreme Judicial Court of Massachusetts offered the following, which is often credited as the origin of the locality rule:

The defendant . . . being the practitioner in a small village . . . was bound to possess that skill only which physicians and surgeons of ordinary ability and skill, practicing in similar localities, with opportunities for no larger experience, ordinarily possess; and he was not bound to possess that high degree of art and skill possessed by eminent surgeons practicing in large cities, and making a specialty of the practice of surgery.(18)

In Brune v Belinkoff,(22) the Supreme Judicial Court of Massachusetts overturned their prior locality ruling in Small v Howard. The Supreme Judicial Court of Massachusetts offered:

A general medical practitioner is to be held to the standard of care and skill of the average qualified practitioner, and a medical specialist is to be held to the standard of care and skill of the average practitioner of the specialty, taking into account with respect to either the general practitioner or the specialist the advances in the profession and the medical resources available to him.(22)

Thus, Brune ruled a specialist should be held to the standard of care and skill of the average member of the profession practicing the specialty, taking into account the advances in the profession.

Emergence of a National Standard of Care

The locality rule was established before the standardization of medical training and certification, which, critics argue, eliminated the need for a locality rule. The accreditation of allopathic medicals schools in the United States is granted by the Liaison Committee on Medical Education (LCME) through compliance with national, not local, standards. The LCME is recognized by the U. S. Department of Education as the reliable authority for the accreditation of medical education programs leading to a Doctor of Medicine degree.(23,24) The locality rule is now difficult to justify, because medical education has become more standardized, and modern technology provides rural physicians with the same access to information for patient care as is available to urban physicians.

The Accreditation Council for Graduate Medical Education (ACGME), founded in 1981, accredits all U. S. clinical residency and fellowship programs.(25) The ACGME accredits organizations that provide continuing medical education that has a national focus. Medical board certification examinations, administered by the member boards of the American Board of Medical Specialties since 1933, are national in scope. Although medical school training, medical licensing requirements, and board certification requirements are based on national standards, some states continue to rely on local practice standards to determine the applicable standard of care in medical malpractice lawsuits.

Brune overturned Small based on the reasoning that there is an established national basis to the training and certification of medical education. A national standard of care presupposes that rural physicians will have the same training, and exercise the same level of judgment and diligence, as urban practitioners. It does not require that rural physicians have the same available medical facilities. For example, if the community does not have facilities for emergency surgery, physicians cannot be found negligent for failing to perform this surgery within the amount of time that might constitute the standard in a well-equipped urban hospital. Because there would still be differences in available resources, physicians practicing under a national standard would need to alert patients to the lack of necessary facilities or resources. Advances in modern medicine and the ease of access to those advances regardless of practice location give further support for the eradication of the last vestiges of the locality rule in United States.

The Failure of Clinical Practice Guidelines to Serve as a Standard of Care

In the 1970s and 1980s, the literature regarding healthcare costs, common practices, and outcomes exploded.(26-29) Research demonstrated that medicine was practiced differently depending on location. For example, patients in Miami spent twice as much time in the hospital and intensive care units as similar patients in Minneapolis.(26) In addition, costs for comparable populations differed markedly across the United States. Gawande(27) reported that, in 2006, the average Medicare enrollee in McAllen, Texas, received approximately $15,000 per year in medical services, twice as much as comparable patients in the nearby and sociodemographically similar El Paso. Such disparities represent, in part, local differences in medical culture, including the degree to which communities practice defensively, especially if the science is imprecise.

Because of these marked healthcare delivery inconsistencies, the United States Congress heeded the call for improvements in 1989 by creating the Agency for Healthcare Research and Quality (AHRQ). (28) This organization was charged with creating specialty-specific clinical practice guidelines to align the fragmented practice of medicine in America. The AHRQ defined practice guidelines as “systematically developed statements [to] assist health care practitioners and patients to make decisions about appropriate health care for specific clinical circumstances.”(30)

Professional medical societies, state governments, liability insurers, and health insurance companies followed suit and created their own guidelines. The AHRQ hoped that practice guidelines would result in a more uniform practice of medicine. In addition, the guidelines would provide a host of other benefits, including effective dissemination of research findings into clinical practice, promotion of patient safety, and reduction in the rising cost of health care.(31, 32) Regarding healthcare costs, the goal was to diminish the practice of both defensive and offensive medicine. The latter refers to reducing the frequency of unnecessary interventions performed by physicians purely for financial gain. In establishing these guidelines, the intent was not to establish the standard of care for medical practice. Nonetheless, many states hoped that, through the creation of these guidelines, adherent practitioners could be shielded from frivolous litigation, eventually reducing the practice of defensive medicine.(29) According to the AHRQ, as of 2017, there were more than 8000 individual guideline summaries for all medical specialties.(33) It is easy to conclude that, at best, many provide redundant information and, at worst, they provide conflicting information, thus undermining their primary intent.

These guidelines have several pitfalls that limit their usefulness in unifying the practice of medicine and providing a concise summary of appropriate medical care for specific clinical circumstances. First, many guidelines become outdated because of new research and practices. After approximately six years, only half of all practice guidelines on the AHRQ website were valid.(34) The rapid expiration of guidelines requires large expenditures of time and money that can hamper effective dissemination of concise recommendations. Second, many of the guidelines conflict with each other, even when created contemporaneously. Third, many of the guidelines lacked the requisite scientific evidence to support their recommendations.(35) Furthermore, some guidelines note that relevant older literature was explicitly excluded from the guidelines for practical purposes, to streamline literature review. Finally, guidelines established by private health insurance companies, liability insurers, and the pharmaceutical industry, groups without fiduciary responsibilities to patients, often are biased. Guidelines created by these entities should be viewed with some skepticism because of inherent financial conflicts. Nor are guidelines that are issued by professional medical societies immune from bias, because many authors have significant relationships with industry.(36) Many physicians surveyed did not know that guidelines existed online. Even those aware of the guidelines objected to following them, for various reasons, including an aversion to practicing “cookbook” medicine, the wish to adhere to non–evidence-based recommendations, and the desire to maintain autonomy. Even though the creation of practice guidelines was not intended to set the standard of care, artful attorneys have found that these widely published standards, despite their many pitfalls, could be persuasive to juries in malpractice litigation, especially those guidelines created by professional medical societies. The Federal Rules of Evidence (37) and the landmark case of Daubert v. Merrell Dow Pharmaceuticals, Inc. paved(38) the way for entering medical treatises as evidence. Plaintiff attorneys attempt to use clinical practice guidelines as a “sword,” or as inculpatory evidence. Defense attorneys attempt to use clinical practice guidelines as a “shield,” or as exculpatory evidence.(39)

The Medical Organization and Medical Errors/Violations and Negligence

Most physicians practicing medicine today are employed by an organization. Inherent to that employment are relative value unit (RVU) quotas and other metrics that grade the physician’s performance. These quotas and metrics mandate that physicians must see many patients and work long hours, often resulting in fatigue. Emanating from this employment relationship is an increased risk for medical errors and violations. It seems logical, therefore, that organizations should shoulder some of this risk and develop systematic approaches to prevent medical errors (skill-based, rules-based, technical, and knowledge-based) and violations in an attempt to provide the highest quality and safest approach to patient care. It will take a focused, coordinated effort among physicians, administrators, and the available technology to reduce the likelihood of adverse events and outcomes.

Discussion

This review of the standard of care and medical errors/violations and their relation to medical negligence law highlights the complexity of evaluating the standard of care physicians must meet in this fast-paced, exponential, corporate, and digital medical world. There does not appear to be a standard of disclosure to which physicians can adhere to avoid liability with any certitude. The standard of care has been and remains obscure, dependent on the circumstances presented in each individual case. The key to improving clarity for physicians is to develop an understanding of the underpinnings of potential negligence (e.g., were the actions taken reasonable and foreseeable?). Additionally, there must be an understanding that the insights gleaned from hindsight and outcomes should not be construed to be necessary components of the physician’s deliberation prior to medical and surgical decisions. Hindsight is always 20/20. These concepts are central to how the courts determine whether blame is to be attributed to a physician’s actions. Physicians also must be aware that they live in a world generally governed by a national standard that may impose national guidelines and expert opinion to judge their actions.

Organizations must understand the importance of human factors in medical errors and violation and respond with system approaches that take into account the fact that to be human is to err. There must be systematic approaches that reduce the potential for skill-based, rule-based, knowledge-based, and technical errors, as well as rule violations. If the system has not acted to counteract these well-known precipitants of medical errors, it should shoulder a significant degree of the burden for alleged negligence.

Finally, experts who are retained in medical malpractice cases must remember that the standard of care may vary among jurisdictions in the United States. Practice guidelines, although intended to unify and improve the practice of medicine, often fail to provide sufficient clarity because of age, conflicting recommendations, various levels of evidential support, and underutilization by practitioners. In many cases, the standard of care is determined de novo and is a moving target. This is one reason why static documents, guidelines, and algorithms are not quite coextensive with the requirements of the legal system. Furthermore, learned medical treatises do not constitute evidence per se. Rather, they are elements of the experts’ opinions that may be introduced into evidence at trial.

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