What Does the Medical Profession Mean By “Standard of Care?”

Standard of Care


Reprinted with permission “The American Society of Clinical Oncology

What Does the Medical Profession Mean By “Standard of Care?”



1. Dirk C. Strauss and
2. J. Meirion Thomas

+ Author Affiliations

1. Melanoma/Sarcoma Unit, Royal Marsden Hospital National Health Service Foundation Trust, London, United Kingdom

To the Editor:

We searched for the exact phrase “standard of care” in the 2009 American Society of Clinical Oncology Annual Meeting Abstracts and found that the term has been used in a total of 70 abstracts covering a wide range of subjects. It is not our intention to judge whether or not the phrase was justified in each setting, and indeed, we are not qualified to do so. However, because the term standard of care is now used so freely in everyday medical discussion, we thought it could be useful to review its derivation, legal implication and how it relates to allied terms such as guidelines and consensus statements, all of which are continuously evolving as new evidence accumulates.

There is no medical definition for standard of care, although the term is firmly established in law and is defined as “the caution that a reasonable person in similar circumstances would exercise in providing care to a patient.”1 The term represents an essential component of an action in medical malpractice in proof that the doctor in question failed to provide the required standard of care under the circumstances. In wider terms, a physician has a duty to exercise the degree of care expected of a minimally competent physician in the same specialty and under the same circumstances. As far back as 1860, the Supreme Court of Illinois issued its first decision on what constitutes standard of care.2 The lawsuit claimed that a physician, who was represented by a then-practicing attorney Abraham Lincoln, had been negligent for improperly applying a plaster cast. The court declared, “When a person assumes the profession of physician and surgeon, he must…be held to employ a reasonable amount of skill and care.” Currently, the standard of care in a malpractice case is established through the testimony of physicians who are considered experts in the field relating to the specific malpractice case. The Supreme Court in Daubert v. Merrell Dow Pharmaceuticals Inc3 held that expert testimony must meet two requirements. Firstly, the evidence presented must be shown to constitute scientific knowledge, and secondly, the evidence must be relevant to the case in question. The Supreme Court further identified a number of factors that may be used to determine whether evidence submitted as scientific knowledge is valid. This includes whether the theory or technique has been tested as scientifically valid, whether the idea has been subjected to scientific peer review or published in scientific journals, whether the theory or technique is generally accepted as valid by the relevant scientific community, and whether standards have been circulated to govern the operation of the technique and the known or potential rate of error involved in the technique. It focuses on methodology and principles, not only on the ultimate conclusions generated.3

Traditionally, the standard of care in English law has been determined according to the Bolam test. The locus classicus of the test for the standard of care required from a doctor has developed from the landmark case Bolam v Frien Hospital.4 This widely known case defined one component of a negligent act, namely a breach in standard of care expected from a medical professional. The principal criticism of the Bolam test is that it has extended beyond its intended limits, and allows the standard in law to be set subjectively by expert witnesses. In the case of Maynard,5 Lord Scarman stated that: “For the realm of diagnosis and treatment, negligence is not established by preferring one respectable body of professional opinion to another.” In an attempt to compensate for this shortcoming, judgment given by the House of Lords in the recent case of Bolitho6 imposes a requirement that the standards proclaimed must be justified on a logical basis and must have considered the risks and benefits of competing options. Thus with no clear medical definition for standard of care, it remains unclear how this mainly legal concept of standard of care weighs up and compares in status to consensus statements or clinical guidelines that are secured in evidence-based medicine and produced by a representative organization or authoritative medical body.

The National Institutes of Health Consensus Development Program states that consensus statements should represent views from a broad-based, nonadvocating, balanced, and objective panel of experts providing a collective agreement keeping in mind that a high degree of variation is still possible among individuals. This further prevents investigations or treatment being declared standard of care based on single studies, often not representing the best or highest level of evidence.7
Clinical practice guidelines produced by specialist associations, US government agencies and health care organizations are collated by the National Guideline Clearinghouse in order to assist practitioners and patient decisions about appropriate healthcare in specific clinical circumstances.8 The difficulty inherent in guidelines that are based in part on consensus is that the biases of the experts may shape the guideline and either exclude reasonable choices or incorporate personal favorites as preferred options.9 The National Comprehensive Cancer Network has suggested that to minimize the possibility of bias, panels issuing guidelines should reflect all schools of thought for a particular condition, and further employ the process of iteration and broad-based feedback. Experts involved in the process of producing clinical guidelines should also declare any conflict of interest. Users of guidelines should be given information about how the recommendation was derived and upon what level of evidence they are based.10

Modern and scientific healthcare should be firmly set in evidence-based medicine, defined as the conscientious, explicit, and judicious use of the current best evidence in making decisions about the care of individual patients.11 Therefore the term standard of care should be used with caution. Currently, it can be self-awarded either by a group of like-minded individuals or by a specialist society or organization and is a term which can be abused with the intention of providing impact and authenticity to a point of view. At worst it could be considered to be self-promoting. This possibility is acknowledged by the National Institutes of Health Consensus Development Program, which states the following, “Most other scientific and medical conferences rely on content experts to make recommendations; however, this raises the possibility of potential conflicts of interest given the expert's financial and career ties to the topic.”7 Without entering into any specific controversy, there may be examples in the literature of treatments which have been claimed to be standard of care without sufficient supporting evidence. Perhaps the term should not be used unless supported by confirmatory randomized controlled trials or meta-analysis that are unchallenged, because the presumed authority of the term may be used in a court of law to the detriment of a minority-view defendant who may think differently and who may be able to present an evidence-based argument to the contrary.

—There is no place in science for consensus or opinion, only evidence.

—–Claude Bernard

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST


The author(s) indicated no potential conflicts of interest.

REFERENCES


1. The Legal Dictionary
Standard of Care. http://legal-dictionary.thefreedictionary.com/standard+of+care.
2. Richie v West, 23 III. 329 (1860).
3. Daubert v Merrell Dow Pharmaceuticals, 509 U.S. 579, 589 (1993).
4. Bolam v Friern Hospital Management Committee, 1 W.L.R. 583, 587 (1957).
5. Maynard v West Midlands Regional Health Authority, 1 W.L.R. 634, 639 (1984).
6. Bolitho v City and Hackney Health Authority, 4 All ER 771 (1997).
7. National Institutes of Health
NIH Consensus Development Program. http://consensus.nih.gov/ABOUTCDP.htm.
8. National Guideline Clearinghouse
Inclusion Criteria. http://www.guideline.gov/about/inclusion.aspx.
9.
  1. Fink A,
    ii Kosecoff J,
    iii Chassin M,
    iv et al.
(1984) Consensus methods: Characteristics and guidelines for use. Am J Public Health 74:979–983.
Medline
10. National Comprehensive Cancer Network
Clinical Recommendations: About the NCCN Clinical Practice Guidelines in Oncology. http://www.nccn.org/professionals/physician_gls/about.asp#catcons.
11.
  1. Sackett DL,
    ii Rosenberg WM,
    iii Gray JA,
    iv et al.
(1996) Evidence-based medicine: What it is and what it isn't. BMJ 312:71–72
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