VOLUME 27 䡠 NUMBER 32 䡠 NOVEMBER 10 2009
JOURNAL OF CLINICAL ONCOLOGY C O R R E S P O N D E N C E
What Does the Medical Profession
Mean By “Standard of Care?”
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 discus-
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sion, we thought it could be useful to review its derivation, legal
implication and how it relates to allied terms such as guidelines and
Copyright © 2024 American Society of Clinical Oncology. All rights reserved.
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 provid-
ing 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 circum-
stances. In wider terms, a physician has a duty to exercise the degree of
care expected of a minimally competent physician in the same spe-
cialty 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 testi-
mony 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 scientifi-
cally 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 deter-
mined 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 de-
e192 © 2009 by American Society of Clinical Oncology
fined 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 at-
tempt 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 rep-
resentative organization or authoritative medical body.
The National Institutes of Health Consensus Development Pro-
gram states that consensus statements should represent views from a
broad-based, nonadvocating, balanced, and objective panel of ex-
perts 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 per-
sonal 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 recommenda-
tion 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 Pro-
gram, 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
Journal of Clinical Oncology, Vol 27, No 32 (November 10), 2009: pp e192-e193
 Correspondence
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 differ-
ently 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
Dirk C. Strauss and J. Meirion Thomas
Melanoma/Sarcoma Unit, Royal Marsden Hospital National Health Service
Foundation Trust, London, United Kingdom
Downloaded from ascopubs.org by 36.71.143.107 on February 29, 2024 from 036.071.143.107
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
The author(s) indicated no potential conflicts of interest.
Copyright © 2024 American Society of Clinical Oncology. All rights reserved.
■ ■ ■
www.jco.org
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. Fink A, Kosecoff J, Chassin M, et al: Consensus methods: Characteristics
and guidelines for use. Am J Public Health 74:979-983, 1984
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. Sackett DL, Rosenberg WM, Gray JA, et al: Evidence-based medicine:
What it is and what it isn’t. BMJ 312:71-72, 1996
DOI: 10.1200/JCO.2009.24.6678; published online ahead of print at
www.jco.org on September 21, 2009
© 2009 by American Society of Clinical Oncology e193