Legal and evidenced-based definitions of standard of care: Implications for code of ethics of professional medical societies
- Professor of Clinical Neurosurgery, School of Medicine, State University of N.Y. at Stony Brook, New York, USA
- Chief of Neurosurgical Spine and Education, NYU Winthrop Hospital, NYU Winthrop Neuro Science, Mineola, New York, USA
Nancy E. Epstein
Professor of Clinical Neurosurgery, School of Medicine, State University of N.Y. at Stony Brook, New York, USA
Chief of Neurosurgical Spine and Education, NYU Winthrop Hospital, NYU Winthrop Neuro Science, Mineola, New York, USA
DOI:10.4103/sni.sni_373_18Copyright: © 2018 Surgical Neurology International This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
How to cite this article: Nancy E. Epstein. Legal and evidenced-based definitions of standard of care: Implications for code of ethics of professional medical societies. 18-Dec-2018;9:255
How to cite this URL: Nancy E. Epstein. Legal and evidenced-based definitions of standard of care: Implications for code of ethics of professional medical societies. 18-Dec-2018;9:255. Available from: http://surgicalneurologyint.com/surgicalint-articles/9151/
Background:The concept “standard of care” (SOC) is invoked in legal cases, as well as evidence-based, and professional/ethical discussions in medicine and surgery.
Methods:We reviewed key legal cases and relevant evidence-based medical articles, and then explored the implications for professional societies seeking to set guidelines for their members testifying as expert witnesses.
Results:First, the legal concept of SOC plays a role in malpractice cases in assessing whether a physician's behavior was “within the SOC.” The concept of SOC has evolved from a “standard of a responsible body of medical opinion” (Bolam case), which implicitly did not allow for multiple SOC, to a more evidence-based approach. Second, according to the evidence-based medical literature, there is more than one SOC in medicine and surgery, including neurosurgery. Third, professional, medical, and surgical societies have evoked the concept of SOC to set ethical guidelines for how their members should behave when testifying as expert witnesses. Specifically, the literature argues societies should avoid abusing singular, self-serving definitions of the SOC to sanction members, typically plaintiff's experts, who offer alternative SOC in depositions or in court.
Conclusions:Recent legal decisions suggest that testimony should be based upon scientific evidence. The scientific evidence indicates that there is often more than one SOC. Thus, any subspecialty society, including the American Association of Neurological Surgeons, that ignores evidence-based medicine and the existence of multiple SOC, risks the appearance of fostering self-interest at the expense of patient care.
Keywords: Standard of Care, Definitions, Bolam Test, Medicine, Best Practice, Bolitho, United Kingdom, Guidelines: Neurosurgery
The concept “standard of care” (SOC) is invoked in legal cases, as well as evidence-based, and professional/ethical discussions in medicine and surgery.First, legally, the concept of SOC plays a role in malpractice cases in assessing whether a physician's behavior was “within the SOC.” Second, there is an evidence-based medical literature that evaluates whether alternative methods and procedures are part of the SOC. Third, professional, medical, and surgical societies have evoked the concept of SOC to set ethical guidelines for how their members should behave when testifying as expert witnesses. Ideally, these three approaches should agree. Here, we review key legal cases and relevant evidence-based medical articles, and them explore the implications for professional societies seeking to set guidelines for their members testifying as expert witnesses.
The SOC in medicine and surgery has been variously defined in both British and U.S. case law. Here, we summarize landmark decisions.
Case of Bolam v Friern Hospital Management Committee (1957)
The case of Bolam v Friern Hospital Management Committee (FHMC) involved a plaintiff who underwent electroconvulsive therapy for mental illness without receiving a muscle relaxant.[
Comments on the Bolam test
In 1999, Hurwitz et al. evaluated the English National Health Service definition of the SOC based on Bolam v FHMC (1957).[
Further, in 2016, Strauss and Thomas criticized the Bolam test for its extension beyond its “intended limits,” allowing the “standard in law to be set subjectively by expert witnesses,” often ignoring plaintiffs’ arguments.[
1975 Federal Rules of Evidence
In 1975, the US Congress adopted the 702 Federal Rules of Evidence that better defined the SOC for both sides in medicolegal suits.[
Daubert v Merrell Dow Pharmaceuticals, 509 U.S. 579, 589 (1993)
This Daubert case involved two children; Jason Daubert and Eric Schuller, both of whom were born with serious birth defects.[
As Strauss and Thomas pointed out, the Daubert case required that expert testimony must meet two requirements: (1) evidence must constitute scientific knowledge, and (2) the evidence must be relevant to the case.[
Bolitho v City and Hackney Health Authority, 4 All Er 771 (1997)
In 2003, Samanta and Samanta noted a shift from the traditional Bolam test to a test based upon the Bolitho v City and Hackney Health Authority case.[
Montgomery v Lanarkshire Health Board (2015)
Montgomery v Lanarkshire Health Board (2015 UK) altered the Bolam test by emphasizing the “general duty” physicians have to clearly disclose risks of procedures/operations (e.g. providing informed consent) to patients.[
Summary of Legal Precedent re: SOC
The historical trend is clear. The Bolam test is paternalistic, e.g. the “doctors know best.” The SOC was defined as “reasonable practice supported by a responsible body of similar professionals.” The Supreme Court in the Daubert case emphasized that experts’ testimony had to be evidence-based. Bolitho challenged Bolam, emphasizing the need to hear alternative opinions from witnesses for the plaintiff; “the standard (of care) proclaimed must be justified on a logical basis and must have considered the risks and benefits of competing options.” Thus, consideration of SOC arguments now had to include a more balanced input from both the defense and plaintiffs’ experts, moving away from long-standing paternalism in favor of greater reliance on evidence-based medicine. Furthermore, bias in favor of “all knowing” defendant physicians had to be challenged as patients were increasingly granted the right to make their own “intelligent” decisions based on a greater preponderance of evidence.
Using evidence-based medicine, several studies concluded that there are multiple definitions of the SOC.[
SOC as applied to Oncology and Medicine
In 2016, Strauss and Thomas looked at 70 abstracts from the American Society of Clinical Oncology Annual Meeting.[
SOC in Dentistry
In dentistry, Jenson et al. in 2014 evaluated and compared the medical vs. ethical definitions of the SOC.[
SOC in Electronic Fetal Monitoring
Spector-Bagdady et al. in 2017 evaluated what was in the best interest of the patient, and simultaneously the “state of the art” SOC for electronic fetal monitoring.[
SOC in Neurosurgery
In neurosurgery, there are multiple SOC defining the appropriate timing of surgery for acute Cauda Equina Syndrome (CES).[
There also appears to be no single SOC for where spinal cord injury (SCI) patients should be treated.[
The SOC for managing lumbar stenosis/degenerative spondylolisthesis (SDS) has largely focused on instrumented lumbar fusions. However, Abdu et al. (2018) in the recent Spine Patient Outcomes Research Trial (SPORT) study documented comparable outcomes for noninstrumented posterolateral, instrumented posterolateral, and 360 fusions (e.g., TLIF [transforaminal lumbar interbody fusions] and PLIF [posterior lumbar interbody fusions]).[
Outcomes of different spine operations now require valid evidence-based data obtained through randomized controlled trials (RCTs) to document their safety and efficacy. As documented by Abdu et al. (2018) in their RCT, no individual neurosurgeon or neurosurgical society can claim any longer that one “fusion” technique is superior to another or is THE SOC. Hence, the SOC is no longer the purview of self-interest or bias, but is rather determined by data.
According to Strauss and Thomas, there are major shortcomings in the definitions of the SOC in different subspecialty societies.[
What are the implications when professional societies set SOC guidelines for their members testifying as expert witnesses?First, guidelines should emphasize that the SOC be evidence-based. Second, it should be explicitly acknowledged that there are multiple SOC and that the appropriate SOC may depend upon the circumstances of an individual patient. Third, they should avoid the appearance of self-interest and place the best interests of the patients first and foremost.
American Association of Neurological Surgeons (AANS)
As an example of a surgical society that I am most familiar with, let us examine the “Expert Witness Rules and Codes of Ethics” of the American Association of Neurological Surgeons (AANS). These rules do not clearly define what the AANS means by SOC nor whether the AANS thinks the SOC varies based upon the requirements of an individual patient. Further, the rules do not preclude their Professional Conduct Committee (PCC) from taking a narrow interpretation dangerously close to the Bolam test. For example, consider Expert Opinion Rule A.4. “The neurosurgical expert witness shall recognize and correctly represent the full standard of neurosurgical care and shall with reasonable accuracy state whether a particular action was clearly within, outside of, or close to the margins of the standard of neurosurgical care.” The rules do not clearly state, as recommended, that there is not just one SOC, and that the SOC may depend upon the circumstances of a particular patient. Additionally, the rules are not even explicit about the need for evidence-based definitions of the multiple SOC in question. Further, the failure to explore these multiple SOC raises a major concern regarding bias at best, and self-interest at worst.
Recent legal decisions suggest that testimony should be based upon scientific evidence. The scientific evidence indicates that there is often more than one SOC. Thus, any subspecialty society, including the AANS, that ignores evidence-based medicine and the existence of multiple SOC, risks the appearance of fostering self-interest at the expense of patient care.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of the Journal or its management.
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